125742 S1 M5 CRF c4591001 1149 11491313

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
334
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is
equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811861
Page 2 of 334
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/24/2020
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811862
Page 3 of 334
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11491313]
2.Birth Date: /1952
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811863
Page 4 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811864
Page 5 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811865
Page 6 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811866
Page 7 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[lyrica allergy]
Start Date: UNK/UNK/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[gabapentin allergy]
Start Date: UNK/UNK/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[partial denture - WEARER]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: Jan/UNK/2020
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[intermittent heart murmur]
Start Date: UNK/UNK/1954
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hyperlipidemia]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811867
Page 8 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[left thumb osteoarthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[right knee osteoarthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[lumbar degenerative disc disease]
Start Date: UNK/UNK/2013
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[femoral hernia]
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2020
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hernia]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811868
Page 9 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811869
Page 10 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
2.Weight: [72.8]
3.Unit: kg
4.Height: [152.0]
5.Unit: cm
6.Body Mass Index: [31.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811870
Page 11 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811871
Page 12 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/24/2020
2.Randomization Number: [265035]
3.Randomization Group: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811872
Page 13 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLCBTS]
5.bSample ID [BLCBTT]
5.cSample ID [BR7WBB]
5.dSample ID [BR7WBC]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811873
Page 14 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7WB9]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811874
Page 15 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 13:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811875
Page 16 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811876
Page 17 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811877
Page 18 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [35.8]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811878
Page 19 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811879
Page 20 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7WR8]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811880
Page 21 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 12:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811881
Page 22 of 334
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020 Comments
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811882
Page 23 of 334
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[this was a combined with convalescent visit. Blood sample was collected and barcoded in
Convalescent visit.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811883
Page 24 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811884
Page 25 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/3/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/5/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811885
Page 26 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locatio
nAssay Code and Descriptio
nDevice Typ
eForm Instance
 1.Unknown  Unknown  Unknown  Unknown  Unknown  Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811886
Page 27 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Unknown
//Comments
2.Specimen Type: Unknown Comments
3.Specimen Collection Location: Unknown Comments
4.Assay Code and Description: Unknown Comments
5.Device Type: Unknown Comments
6.Trade Name: Unknown Comments
7.Test Result: Unknown Comments
8.Comments/Findings/Details: Unknown
[ ]Comments
9.Trade Name Other, Specify: Unknown
[ ]Comments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811887
Page 28 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Subject is admitted to the hospital and doesn't have self swab kit with her.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811888
Page 29 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Subject is admitted to the hospital and doesn't have self swab kit with her.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811889
Page 30 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811890
Page 31 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Nov/1/2020  NO
Discharge Date:
Nov/13/2020
 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811891
Page 32 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/1/2020
4.Ongoing? NO
Discharge Date:
Nov/13/2020
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811892
Page 33 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applicable
 Not Applicable
 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811893
Page 34 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811894
Page 35 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811895
Page 36 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811896
Page 37 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811897
Page 38 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
 1.CLINICAL C
HEMISTRY Los Alamitos Medical Center,3751 K
atella Avenue, Los Alamitos, CA 907
20 Nov/1/2
020 BLOOD
 Sponsor-Defi
ned Identifie
rTest:Res
ult:
329  C Reactive Protei
n_PX329 [ ] 
30  Alanine Aminotr
ansferase_PX30 23 
28  Aspartate Amino
transferase_PX2
8 20 
35  Alkaline Phospha
tase_PX35 68 
21  Bilirubin_PX21  [ ] 
47  Blood Urea Nitro
gen_PX47 18 
48  Creatinine_PX48
 1.0 Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811898
Page 39 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Los Alamitos Medical Center,3751 Katella Avenue, Los Alamitos, CA 90720]
3.Collection Date: Nov/1/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [23]
Not Done:
LNMT Low
[7]
High
[35]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [20]
Not Done:
LNMT Low
[8]
High
[20]
Unit
U/L
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811899
Page 40 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [68]
Not Done:
LNMT Low
[38]
High
[136]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [18]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.0]
Not Done:
LNMT Low
[0.6]
High
[20]
Unit
mg/dL
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811900
Page 41 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOLO
GY Los Alamitos Medical Center, 3751
Katella Avenue CA, 90720 Nov/1/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 12.1 
2  Hematocrit_
PX2 36.6 
3  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 221 
7  Leukocytes_
PX7 [ ] 
608  Neutrophils_
PX608 2.4 
609  Eosinophils_
PX609 0.2 
612  Monocytes_
PX612 0.5 
610  Basophils_P
X610 0.1 
611  Lymphocyte
s_PX611 2.2 Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811901
Page 42 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Los Alamitos Medical Center, 3751 Katella Avenue CA, 90720]
3.Collection Date: Nov/1/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.1]
Not Done:
LNMT Low
[12.0]
High
[15.6]
Unit
10^3/uL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.6]
Not Done:
LNMT Low
[35.0]
High
[46.0]
Unit
10^3/uL
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811902
Page 43 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [221]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [2.4]
Not Done:
LNMT Low
[1.0]
High
[7.8]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.6]
Unit
10^3/uL
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811903
Page 44 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.2]
High
[1.1]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.2]
Not Done:
LNMT Low
[0.8]
High
[4.1]
Unit
10^3/uL
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811904
Page 45 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Nov/3/2020 Record Identifier: Systolic: Diastolic:
1  180  85 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811905
Page 46 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 2. DELETED Nov/3/2020 Record Identifier: Systolic: Diastolic:
1  180  85 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811906
Page 47 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [180]
Diastolic: [85]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [110]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811907
Page 48 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [180]
Diastolic: [85]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [110]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811908
Page 49 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Nov/3/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811909
Page 50 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 2. DELETED Nov/3/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811910
Page 51 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811911
Page 52 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811912
Page 53 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811913
Page 54 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811914
Page 55 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811915
Page 56 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811916
Page 57 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Oct/30/2020  HEAD  CT SCAN  NORMAL  Repeating Pages
 2.Oct/31/2020  OTHER
If other, specify:
Neck
 MRI  NORMAL  Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811917
Page 58 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/30/2020
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811918
Page 59 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/31/2020
2.Location of Assessment: OTHER
If other, specify:
[Neck]
3.Type of Imaging Exam: MRI
4.Assessment: NORMAL
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811919
Page 60 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Dec/10/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811920
Page 61 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ947]
5.bSample ID [BRVJYJ]
5.cSample ID [BRVJYK]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811921
Page 62 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811922
Page 63 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811923
Page 64 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811924
Page 65 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811925
Page 66 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Acute Trauma Head Inj
ury Oct/30/2020 08:00  NO
End Date Time:
Nov/3/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Cervicogenic headache
 Oct/30/2020 UNK:UN
K NO
End Date Time:
Nov/3/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EVE
NT 3  fall  Oct/UNK/2020 UNK:U
NK NO
End Date Time:
Oct/UNK/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVE
NT 4  fall  Oct/UNK/2020 UNK:U
NK NO
End Date Time:
Oct/UNK/2020 UNK:UNK
 Repeating
Pages
 5.ADVERSE EVE
NT 5  fall  Oct/UNK/2020 UNK:U
NK NO
End Date Time:
Oct/UNK/2020 UNK:UNK
 Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811926
Page 67 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Trauma Head Injury]
4.Start Date Time: Oct/30/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[3 subsequent falls]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811927
Page 68 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020427994]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811928
Page 69 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cervicogenic headache]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Head Trauma]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811929
Page 70 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020427994]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811930
Page 71 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/UNK/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811931
Page 72 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811932
Page 73 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/UNK/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811933
Page 74 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811934
Page 75 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/UNK/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811935
Page 76 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811936
Page 77 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
 1.          Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811937
Page 78 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811938
Page 79 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811939
Page 80 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811940
Page 81 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811941
Page 82 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811942
Page 83 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811943
Page 84 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811944
Page 85 of 334
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811945
Page 86 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811946
Page 87 of 334
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811947
Page 88 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811948
Page 89 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811949
Page 90 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811950
Page 91 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811951
Page 92 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811952
Page 93 of 334
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811953
Page 94 of 334
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811954
Page 95 of 334
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811955
Page 96 of 334
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811956
Page 97 of 334
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811957
Page 98 of 334
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811958
Page 99 of 334
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811959
Page 100 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811960
Page 101 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811961
Page 102 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811962
Page 103 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811963
Page 104 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811964
Page 105 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7WGZ]
5.bSample ID [BSGTFS]
5.cSample ID [BSGTFT]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811965
Page 106 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7WGY]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811966
Page 107 of 334
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 13:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811967
Page 108 of 334
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811968
Page 109 of 334
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811969
Page 110 of 334
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7WF6]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811970
Page 111 of 334
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/12/2021 11:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811971
Page 112 of 334
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811972
Page 113 of 334
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/12/2021
3.Comments: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811973
Page 114 of 334
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811974
Page 115 of 334
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811975
Page 116 of 334
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811976
Page 117 of 334
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811977
Page 118 of 334
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811978
Page 119 of 334
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811979
Page 120 of 334
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811980
Page 121 of 334
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811981
Page 122 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-25-2020 07:50:02 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811982
Page 123 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811983
Page 124 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Sep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811984
Page 125 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Sep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811985
Page 126 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811986
Page 127 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Sep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811987
Page 128 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Sep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811988
Page 129 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811989
Page 130 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811990
Page 131 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-25-2020 07:56:01 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811991
Page 132 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Jan-12-2021 09:27:14 (UTC-08:00) Pacific Time (US
& Canada)
1Nov-25-2020 10:14:45 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811992
Page 133 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but
not aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811993
Page 134 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811994
Page 135 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811995
Page 136 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811996
Page 137 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811997
Page 138 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811998
Page 139 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811999
Page 140 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812000
Page 141 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812001
Page 142 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Nov-04-2020 15:06:02 (UTC-08:00) Pacific Time (US
& Canada)per subject got tested and it came back negative but not
aware of more details.
Unknown
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812002
Page 143 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812003
Page 144 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812004
Page 145 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812005
Page 146 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812006
Page 147 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812007
Page 148 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812008
Page 149 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Nov-16-2020 13:35:47 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812009
Page 150 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-25-2021 10:13:39 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812010
Page 151 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812011
Page 152 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Jan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812012
Page 153 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Jan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812013
Page 154 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Jan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812014
Page 155 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Jan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812015
Page 156 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Jan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812016
Page 157 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812017
Page 158 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812018
Page 159 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 10:14:04 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812019
Page 160 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812020
Page 161 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812021
Page 162 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812022
Page 163 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812023
Page 164 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812024
Page 165 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812025
Page 166 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812026
Page 167 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812027
Page 168 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:11:29 (UTC-08:00) Pacific Time (US
& Canada)Not Applicable
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812028
Page 169 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Nov-19-2020 11:24:06 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven Reynolds  Approved Nov-17-2020 12:36:10 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenReynolds, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812029
Page 170 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-25-2020 07:49:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-25-2020 07:49:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812030
Page 171 of 334
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020 07:49:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/24/2020Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812031
Page 172 of 334
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-04-2020 23:23:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-04-2020 15:00:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered SAE entered in CRF
Nov-04-2020 04:13:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020427994
Severe Cough (onset
date:01Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-25-2020 07:49:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11491313Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 07:49:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-25-2020 07:49:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 07:49:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812032
Page 173 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-25-2020 07:49:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812033
Page 174 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 07:49:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812034
Page 175 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-25-2020 07:50:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 07:50:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 07:50:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812035
Page 176 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-25-2020 07:50:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:lyrica allergy
Start Date: UNK/UNK/201
2
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:50:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:50:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
lyrica allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-25-2020 07:50:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-25-2020 07:50:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-25-2020 07:51:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:gabapentin allerg
yInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812036
Page 177 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Start Date: UNK/UNK/2012
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:51:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:51:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
gabapentin allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-25-2020 07:51:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-25-2020 07:51:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-25-2020 12:34:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:3
Medical History
Term:partial denture - WE
ARER
Start Date: UNK/UNK/2016
Ongoing: YESupdated per query
Sep-25-2020 07:51:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:partial denture
Start Date: UNK/UNK/201
6Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812037
Page 178 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: YES
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812038
Page 179 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:51:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020
15:59:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Sep-25-2020
12:34:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered updated per query
Sep-25-2020
12:34:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
partial denture - WEA
RERupdated per query
Sep-25-2020
09:37:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify the term
PARTIAL
DENTURE as
follows. This is a
device. Please
specify are you
reporting PARTIAL
DENTURE -
WEARER? or
PARTIAL
DENTURE -
PLACEMENT? or
Other? If so, edit to
such. Otherwise
please clarify the
term further. Thank
you.
Sep-25-2020
07:51:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
partial dentureInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-25-2020 07:51:32
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812039
Page 180 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
1.c Ongoing:
Date Location User Value Reason
Sep-25-2020 07:51:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-25-2020 07:51:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: hypertension
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:51:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:51:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-25-2020 07:51:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020 07:51:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812040
Page 181 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-25-2020 07:52:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:intermittent heart m
urmur
Start Date: UNK/UNK/1954
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:52:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:52:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
intermittent heart murmurInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020 07:52:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1954Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020 07:52:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-25-2020 07:52:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Term: hyperlipidemia
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812041
Page 182 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:52:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:52:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
hyperlipidemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-25-2020 07:52:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-25-2020 07:52:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-25-2020 07:53:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Term
:type 2 diabetes
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812042
Page 183 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:53:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:53:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-25-2020 07:53:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-25-2020 07:53:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-25-2020 07:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:left thumb osteoarth
ritis
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812043
Page 184 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.h Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left thumb osteoarthritisInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-25-2020 07:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-25-2020 07:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-25-2020 07:54:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:right knee osteoarth
ritis
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812044
Page 185 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.i Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:54:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 07:54:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
right knee osteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-25-2020 07:54:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-25-2020 07:54:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812045
Page 186 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.j
Date Location User Value Reason
Oct-13-2020 10:54:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:10
Medical Histor
y Term:lumbar degenerative d
isc disease
Start Date: UNK/UNK/2013
Ongoing: YESUpdated per query
Sep-25-2020 12:14:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 10
Medical History Ter
m:lumbar DDD
Start Date: UNK/UNK/201
3
Ongoing: YESUpdated per query
Sep-25-2020 07:54:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Ter
m:lumbar DDD her
nia
Start Date: UNK/UNK/2013
Ongoing: YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812046
Page 187 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.j Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:54:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
11:08:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-13-2020
10:54:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Updated per
query
Oct-13-2020
10:54:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar degenerative di
sc diseaseUpdated per
query
Oct-06-2020
15:56:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Please spell out
degenerative disc
disease
Sep-25-2020
16:00:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Sep-25-2020
12:14:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Updated per
query
Sep-25-2020
12:14:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar DDDUpdated per
query
Sep-25-2020
11:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Multiple concepts
in the term
LUMBAR DDD
HERNIA. Split
the term into
LUMBAR DDD
and LUMBAR
DISC HERNIA
and report as
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b) (4), (b) 
(6)
(b)
(4),
(b)
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812047
Page 188 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
separate entries.
Thank you.
Sep-25-2020
07:54:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar DDD herniaInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-25-2020 07:54:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-25-2020 07:54:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 11
Medical History Te
rm:femoral hernia
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2
020Changed Information
Sep-25-2020 07:55:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Te
rm:hernia repair
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2
020Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812048
Page 189 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.k Line/MH Number:
Date Location User Value Reason
Sep-25-2020 07:55:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 09:22:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-03-2020 14:48:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-03-2020 14:48:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
femoral herniaChanged Information
Oct-25-2020 10:16:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please list the condition
and not the procedure.
Oct-23-2020 18:18:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Hernia added
Oct-06-2020 15:57:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Hernia repair is a
procedure, please list
the reason (Hernia) as
the diagnosis/condition.
Sep-25-2020 07:55:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hernia repairInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-25-2020 07:55:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-25-2020 07:55:07 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812049
Page 190 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)NO
End Date:
UNK/UNK/2020
1.l
Date Location User Value Reason
Oct-23-2020 18:17:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Term
:hernia
Start Date: UNK/UNK/201
3
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Oct-23-2020 18:17:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 18:17:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
herniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-23-2020 18:17:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-23-2020 18:17:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812050
Page 191 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020 07:55:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HIV PO
SITIVEInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812051
Page 192 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
72.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
152.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.5Initial Entry
7.a
Date Location User Value Reason
Sep-25-2020 07:55:41 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812052
Page 193 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Location:: FOREHEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 07:55:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812053
Page 194 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identif
ier:Not Applicab
le
Test:: Not Applicab
le
Result:: Not Applicab
leInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812054
Page 195 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Not Done:: Not Applicab
le
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-25-2020 07:56:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812055
Page 196 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 07:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-30-2020
23:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020
12:25:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Sep-30-2020
12:25:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
265035Transcription
Error
Sep-28-2020
02:42:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Opened As per Impala,
Randomization
Number is 265035
. Please review
and update as
appropriate.
Sep-25-2020
07:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
263035Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812056
Page 197 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 07:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 07:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 08:45:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 07:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-25-2020 07:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 08:45:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCBTSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 08:45:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLCBTSInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812057
Page 198 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b
Date Location User Value Reason
Sep-25-2020 08:45:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCBTTInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-25-2020 08:45:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLCBTTInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020 08:45:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7WBBInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-25-2020 08:45:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR7WBBInitial Entry
5.d
Date Location User Value Reason
Sep-25-2020 08:45:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7WBCInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-25-2020 08:45:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR7WBCInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812058
Page 199 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 07:56:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 07:56:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 09:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 07:56:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-25-2020 07:56:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 09:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7WB9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 09:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR7WB9Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812059
Page 200 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 13:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020 07:57:03 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812060
Page 201 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-25-2020 07:57:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812061
Page 202 of 334
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-25-2020 07:57:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812062
Page 203 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 14:03:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812063
Page 204 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 35.8
Temperature Unit: C
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-23-2020 23:43:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Sandip
Namdeorao
SuryawanshiQuery 1: Closed Response satisfies
query
Oct-23-2020 18:09:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered NCS per MD
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 35.8 C is
outside of Normal
Range 36.1 - 37.5 C.
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
35.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-19-2020 14:06:18
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812064
Page 205 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Oct-19-2020 14:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812065
Page 206 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812066
Page 207 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-19-2020 14:09:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812067
Page 208 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 14:11:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 14:11:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 14:11:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-19-2020 14:11:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7WR8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR7WR8Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812068
Page 209 of 334
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 12:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020 14:11:57 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812069
Page 210 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-19-2020 14:11:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812070
Page 211 of 334
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
06:52:48
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3:
ClosedResponse satisfies query
Jan-24-2021
21:07:59
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2:
ClosedPer site confirmation_Updated
PD tracker
Jan-22-2021
09:15:13
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2:
AnsweredOriginal entry is correct.
Subject was unable to conduct
visit 3 within window.
Jan-22-2021
09:12:51
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3:
AnsweredEOT form has been updated.
Jan-13-2021
02:39:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3:
OpenedDM: The treatment period is
defined as 1st vaccination visit
through the 1-month post
vaccination visit after the 2nd
vaccination. Please complete
treatment disposition CRF and
update date of EOT to match
date of visit at visit 3.
Jan-13-2021
00:11:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Jan-12-2021
21:55:59
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 2:
OpenedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 21 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812071
Page 212 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-12-2021
09:27:41
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredInitial Entry
Jan-12-2021
09:27:41
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Ent
ry:
Dec/10/20
20Initial Entry
Jan-12-2021
09:27:14
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Ent
ry:Initial Entry
Jan-11-2021
23:53:48
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1:
OpenedPlease remove comment and
enter date of visit when the
sample is collected for visit 3.
Nov-25-2020
10:14:45
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Ent
ry:
Not DoneInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812072
Page 213 of 334
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 03:44:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as data updated.
Jan-13-2021 00:27:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-12-2021 09:21:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Jan-12-2021 09:21:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Jan-12-2021 09:21:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Jan-11-2021 23:57:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 2: Opened Per CCG, If blood
sample is combined
with convalescent visit,
then answer this item to
NO. Please review and
update as necessary.
Else clarify.
Dec-13-2020 21:45:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you for
response, Barcode at
convalescent visit were
missing. Please review
and provide the
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812073
Page 214 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
missing data or else
clarify.
Dec-11-2020 15:20:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered this was a combined
with convalescent visit.
Blood sample was
collected and barcoded
in Convalescent visit.
Dec-11-2020 09:33:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-12-2021 21:01:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-12-2021 09:25:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered 'Sample collected'
response has been
changed to No
Dec-13-2020 22:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Response to
'Sample Collected' is
marked as Yes and
sample collection date
provided. However,
reason for sample not
collected is not blank.
Please review and
consider to update the
data accordingly else
clarify.
Dec-10-2020 13:50:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze DOV
to update ecrf
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b)(4),
(b)(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812074
Page 215 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Entered text has either
a carriage return (line
break) or extra spaces
at the end of the text or
between words. Please
correct by removing all
data in the field and
re-enter without adding
extra spaces or using
enter or tab keys.
Dec-10-2020 13:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
this was a combined with convalescent
visit. Blood sample was collected and b
arcoded in Convalescent visit.Initial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812075
Page 216 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020 16:46:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-16-2020 12:38:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered entered
Nov-09-2020 21:51:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly review
and complete ‘Illness
Details form' at this
visit. Thank you.
Nov-05-2020 08:15:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Query closed as per
site response
Nov-05-2020 01:15:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Deleted Duplicate
Nov-04-2020 15:01:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-04-2020 09:19:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Nasal swab not
complete due to
subject having an SAE
and currently in the
hospital. Site to follow
up once subject is
available.
Nov-04-2020 04:19:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-03-2020 15:11:00 ACV0PFEINFP6000  auto query Query 2: Deleted Close Auto Query
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0812076
Page 217 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)(autoquery)
Nov-03-2020 15:10:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Nov-03-2020 15:10:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-03-2020 15:10:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-03-2020 15:10:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0812077
Page 218 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/1/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-22-2021 11:47:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 10:37:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-22-2021 10:37:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Nov/5/2020New Information
Dec-14-2020 05:46:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
clarify whether the
reported symptoms are
still ongoing? If
symptoms have ended,
please update
‘Symptoms Ongoing’
on to ‘NO’ and add
Date of Last Symptom
Resolved on the CRF.
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812078
Page 219 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 
)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATHInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812079
Page 220 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Symptom
Present:NO
4.c Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812080
Page 221 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom Pr
esent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:NOInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812081
Page 222 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.g Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE THROA
TInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812082
Page 223 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-03-2020 15:11:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c8\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812083
Page 224 of 334
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/03/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491313 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-08-2020 22:06:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-06-2020 16:06:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Nov-06-2020 02:28:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please confirm if
Comment entered
needs to be recorded in
appropriate data point.
Please confirm and
correct else clarify,
thank you.
Nov-04-2020 15:06:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-04-2020 15:06:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-04-2020 15:06:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
4. Assay Code and De
…[truncated]
Related across Profoundd

WEF Publications

Sustainable Development Goals — SDG 11 Sustainable Cities p.1
Overview Targets and Indicators Progress and Info Overview High resolution image Goal 11 infographic, source: https://unstats.un.org/sdgs/report/2025/ Targets and Indicators Target 11.1 By 2030, ensure access for all to …
Epstein Files

EFTA00692098 — From: Giuseppe Bersani <giuseppe.bersani®uniromal.it ,
From: Giuseppe Bersani <giuseppe.bersani®uniromal.it , To: Gino Yu "jeffrey E." [email protected]> Cc: Omella Corazza <[email protected]> Subject: Re: Any news? Date: Tue, 21 Feb 2017 09:57:14+0000 Dear Gino, w…
EFTA00692128 — From: Gino Yu < >
From: Gino Yu < > To: Giuseppe Bersani <[email protected]>, "jeffrey E." •rz > Cc: Ornella Corazza <[email protected]> Subject: Re: Any news? Date: Tue, 21 Feb 2017 08:56:05 +0000 Hi Gitseppi, I've my ben…
EFTA02386428 — From: Gino Yu
From: Gino Yu Sent: Tuesday, February 21, 2017 8:56 AM To: Giuseppe Bersani; jeffrey E. Cc: Ornella Corazza Subject: Re: Any news? Hi Giuseppi, I've cc'd my =enefactor, Jeffrey Epstein. He can make arrangements on the =r…
Federal Writers' Project

[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Early Portland Folkways]
Pee -Ors 4"J er,i7vAls -retA",10**ErS, Amnion no. WPA L. C. PROJECT UNIT Form -3 /J-F'd Date received 47, Consignment no. Shipped from Label AV:al-4 514 Amount olv Collection (or Type) Title Date...11,4/ Place of origin …
[Folkways, and Social Customs]
Accession no. W UNIT Form -3 0eAf-,7_4_ Collection (or Type) Date received /0/r.o/re. Consignment no. Shipped from Label Amount Title ..7‘;-erf-1-0,-07.-0.-• Place of origin Date./0,/-17 Project worker Project editor Rem…
Recent News

You Are Part of An Experiment in Consent and Choice
This is a member's only feature. Please join or upgrade Originally published on www.standforhealthfreedom.com As summer melts into fall, informed consent is on the line, with FDA approval of the Pfizer vaccine expected b…
Too Much Sugar Linked to Aggression, ADHD and Bipolar Disorder
This is a member's only feature. Please join or upgrade Discover the bitter truth about high-sugar diets, particularly in how they may be triggering ADHD and aggressive behaviors by overactivating the fructose pathway, a…
Ex-Fauci adviser shared ‘confidential’ NIH info with EcoHealth about COVID biosafety levels: docs
A former senior adviser to National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci shared “confidential” communications with EcoHealth Alliance about how the agency was preparing to respond to ac…