125742 S1 M5 CRF c4591001 1054 10541186

Document text

Page 1 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916189
Page 2 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/23/2020
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916190
Page 3 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10541186]
2.Birth Date: /1949
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916191
Page 4 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916192
Page 5 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916193
Page 6 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916194
Page 7 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: Feb/14/2017
Ongoing: NO
End Date:
Feb/14/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: Feb/14/2017
Ongoing: NO
End Date:
Feb/14/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lactose intolerance]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cyst, R axilla]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916195
Page 8 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916196
Page 9 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
2.Weight: [84.35]
3.Unit: kg
4.Height: [172.72]
5.Unit: cm
6.Body Mass Index: [28.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916197
Page 10 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916198
Page 11 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/23/2020
2.Randomization Number: [264594]
3.Randomization Group: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916199
Page 12 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BPYWXM]
5.bSample ID [BPYWXN]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916200
Page 13 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BPYWXP]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916201
Page 14 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/23/2020 12:32
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916202
Page 15 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916203
Page 16 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916204
Page 17 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916205
Page 18 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916206
Page 19 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:[Pt refused the 2nd vaccine and NP swab due to AEs and discomfort respectively, but
is willing to come for future study visits.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916207
Page 20 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916208
Page 21 of 179
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916209
Page 22 of 179
***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, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BM98DC]
5.bSample ID [BM98DD]
5.cSample ID [BM98DF]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916210
Page 23 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916211
Page 24 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916212
Page 25 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916213
Page 26 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916214
Page 27 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916215
Page 28 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916216
Page 29 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916217
Page 30 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916218
Page 31 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916219
Page 32 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916220
Page 33 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916221
Page 34 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916222
Page 35 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916223
Page 36 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916224
Page 37 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916225
Page 38 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916226
Page 39 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916227
Page 40 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916228
Page 41 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifie
rAdverse Event Start DateIs the Adverse Event Still Ongoi
ngForm Instance
 1.ADVERSE EVEN
T 1  lightheadednes
s Sep/23/2020 12:4
0 NO
End Date Time:
Sep/23/2020 14:40
 Repeating Pages
 2.ADVERSE EVEN
T 2  nausea  Sep/23/2020 12:4
0 NO
End Date Time:
Sep/23/2020 14:40
 Repeating Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916229
Page 42 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[lightheadedness]
4.Start Date Time: Sep/23/2020 12:40
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/23/2020 14:40
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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916230
Page 43 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916231
Page 44 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[nausea]
4.Start Date Time: Sep/23/2020 12:40
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/23/2020 14:40
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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916232
Page 45 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916233
Page 46 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916234
Page 47 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916235
Page 48 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916236
Page 49 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916237
Page 50 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916238
Page 51 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916239
Page 52 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916240
Page 53 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916241
Page 54 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916242
Page 55 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916243
Page 56 of 179
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916244
Page 57 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916245
Page 58 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916246
Page 59 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916247
Page 60 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916248
Page 61 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916249
Page 62 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916250
Page 63 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916251
Page 64 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916252
Page 65 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916253
Page 66 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916254
Page 67 of 179
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916255
Page 68 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916256
Page 69 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916257
Page 70 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021 Comments
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION Comments
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916258
Page 71 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916259
Page 72 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916260
Page 73 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916261
Page 74 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916262
Page 75 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916263
Page 76 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916264
Page 77 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/23/2020
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916265
Page 78 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916266
Page 79 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916267
Page 80 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-24-2020 08:04:56 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916268
Page 81 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916269
Page 82 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916270
Page 83 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916271
Page 84 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916272
Page 85 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916273
Page 86 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916274
Page 87 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916275
Page 88 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916276
Page 89 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-24-2020 08:12:58 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916277
Page 90 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916278
Page 91 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916279
Page 92 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916280
Page 93 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916281
Page 94 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916282
Page 95 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916283
Page 96 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916284
Page 97 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916285
Page 98 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-16-2020 15:56:31 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916286
Page 99 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-16-2020 15:59:08 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
FormOct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916287
Page 100 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916288
Page 101 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916289
Page 102 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916290
Page 103 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916291
Page 104 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916292
Page 105 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916293
Page 106 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916294
Page 107 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916295
Page 108 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916296
Page 109 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
10Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916297
Page 110 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
11Oct-16-2020 15:57:51 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Pt withdrew consent at time of V2 NP swab.
Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916298
Page 111 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-22-2021 09:59:48 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
FormOct-23-2020 08:32:32 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
FormOct-20-2020 13:41:33 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
FormOct-20-2020 13:41:21 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916299
Page 112 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-22-2021 09:59:48 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
1Oct-23-2020 08:32:32 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
1Oct-20-2020 13:41:33 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
1Oct-20-2020 13:41:21 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916300
Page 113 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-22-2021 09:59:48 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
2Oct-23-2020 08:32:32 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
2Oct-20-2020 13:41:33 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi
2Oct-20-2020 13:41:21 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Done
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916301
Page 114 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-23-2020 08:32:17 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916302
Page 115 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-23-2020 08:32:17 (UTC-08:00) Pacific Time
(US & Canada)Steven Choi Not Applicable
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916303
Page 116 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
Steven Choi  N/A Feb-22-2021 09:03:52 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Leibowitz  Approved Nov-16-2020 10:57:12 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkLeibowitz, 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.
Steven Choi  N/A Nov-11-2020 11:35:18 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Leibowitz  Approved Nov-11-2020 10:15:40 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkLeibowitz, 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.
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916304
Page 117 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-24-2020 08:03:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-24-2020 08:03:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916305
Page 118 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-24-2020 08:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
OBTAINED
Date Written Consent Obtained
Sep/23/2020Transcription Error
Sep-24-2020 08:03:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
OBTAINED
Date Written Consent Obtained
Sep/24/2020Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916306
Page 119 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-24-2020 08:03:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10541186Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-24-2020 08:03:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-24-2020 08:04:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-24-2020 08:04:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-24-2020 08:04:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BLACK OR AFRICAN AMERICANInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916307
Page 120 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 08:04:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916308
Page 121 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-24-2020 08:05:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 08:05:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 08:05:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916309
Page 122 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-24-2020 08:06:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:appendicitis
Start Date: Feb/14/2017
Ongoing: NO
End Date:
Feb/14/201
7Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-24-2020 08:06:10
(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-24-2020 08:06:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
appendicitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-24-2020 08:06:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Feb/14/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-24-2020 08:06:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
Feb/14/2017Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916310
Page 123 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Sep-24-2020 08:06:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:appendectomy
Start Date: Feb/14/2017
Ongoing: NO
End Date:
Feb/14/201
7Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-24-2020 08:06:32
(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-24-2020 08:06:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
appendectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-24-2020 08:06:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Feb/14/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-24-2020 08:06:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
Feb/14/2017Initial Entry
1.c
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916311
Page 124 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 08:08:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:lactose intolera
nce
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-24-2020 08:08:39
(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-24-2020 08:08:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
lactose intoleranceInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-24-2020 08:08:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-24-2020 08:08:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-24-2020 08:09:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:cyst, R axillaInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916312
Page 125 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/20
19
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-24-2020 08:09:09
(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-24-2020 08:09:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
cyst, R axillaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-24-2020 08:09:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-24-2020 08:09:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916313
Page 126 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-24-2020 08:09:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916314
Page 127 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
84.35Initial Entry
3. Unit:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
172.72Initial Entry
5. Unit:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.3Initial Entry
7.a
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916315
Page 128 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 08:11:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916316
Page 129 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription Error
Sep-24-2020 08:12:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of collection is
reported, but result is
missing. Please review
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916317
Page 130 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and update as
appropriate.
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:Not Applicable
Test:: Choriogonadotropi
n Beta_PX113
Result:: Not Applicable
Not Done:: Not ApplicableInitial Entry
Sep-24-2020 08:12:16 ACV0PFEINFP6000  auto calc Data Entry: Transcription Error
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916318
Page 131 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific Time
(US & Canada)(autocalc) Sponsor-Define
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done::
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
Sep-24-2020 08:12:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription Error
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916319
Page 132 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-24-2020 08:11:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-24-2020 08:12:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916320
Page 133 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-24-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-24-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
264594Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916321
Page 134 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 08:14:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 08:14:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 08:17:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 08:14:41
(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-24-2020 08:14:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 08:17:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BPYWXMInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 08:17:02 ACV0PFEINFP6000  Steven Data Entry: Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916322
Page 135 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific Time
(US & Canada)Choi BPYWXM
5.b
Date Location User Value Reason
Sep-24-2020 08:17:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BPYWXNInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020 08:17:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BPYWXNInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916323
Page 136 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 08:15:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 08:15:07
(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-24-2020 08:17:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 08:15:07
(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-24-2020 08:15:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 08:17:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BPYWXPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 08:17:28 ACV0PFEINFP6000  Steven Data Entry: Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916324
Page 137 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific Time
(US & Canada)Choi BPYWXP
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916325
Page 138 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 08:15:50
(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-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020 12:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 08:15:50
(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-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
LEFTInitial Entry
7. Route:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916326
Page 139 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-24-2020 08:15:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916327
Page 140 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-24-2020 08:15:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916328
Page 141 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 16:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/14/2020Transcription Error
Oct-16-2020 15:48:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/16/2020Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916329
Page 142 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 16:00:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/14/2020Transcription Error
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916330
Page 143 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-16-2020 15:56:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916331
Page 144 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916332
Page 145 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-16-2020 15:56:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916333
Page 146 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 15:57:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 15:57:08
(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-16-2020 15:57:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-19-2020 08:17:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt refused the 2nd vaccine and NP sw
ab due to AEs and discomfort respecti
vely, but is willing to come for future
study visits.Transcription Error
Oct-16-2020 15:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 15:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt withdrew consent at time of V2 NP
swab.Transcription Error
Oct-16-2020 15:57:08
(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
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916334
Page 147 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the field and re-enter
without adding extra
spaces or using enter
or tab keys.
Oct-16-2020 15:57:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt withdrew consent at time of V2 NP
swab.Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916335
Page 148 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-21-2020
19:58:33
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_EC001_2_06_AN
Oct-21-2020
10:52:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Steven Choi Query
1: Ans
weredQuery is ambiguous
Oct-21-2020
02:39:09
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM:Randomization number is
recorded and the final
disposition date is present on
the Disposition - Follow-up
eCRF, but there is no dosing
date present on the Treatment
eCRF. Please review and
update as appropriate.
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916336
Page 149 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-19-2020
08:20:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Steven Choi Query
1: Ans
weredChanged data per query
Oct-17-2020
01:07:25
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5060540;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Oct-16-2020
15:57:51
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Steven Choi Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916337
Page 150 of 179
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-16-2020 15:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916338
Page 151 of 179
***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, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 11:35:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Nov/11/2020Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916339
Page 152 of 179
***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, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 11:35:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 11:35:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 14:09:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 11:35:26
(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.
Nov-11-2020 11:35:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 14:09:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BM98DCInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 14:09:24 ACV0PFEINFP6000  Steven Data Entry: Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916340
Page 153 of 179
***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, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific Time
(US & Canada)Choi BM98DC
5.b
Date Location User Value Reason
Nov-11-2020 14:09:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BM98DDInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020 14:09:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98DDInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020 14:09:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BM98DFInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020 14:09:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98DFInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916341
Page 154 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916342
Page 155 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916343
Page 156 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
lightheadednessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020 12:40Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date Time:
Sep/23/2020 14:40Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916344
Page 157 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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).
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 05:18:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed STAT, SPA confirmed
it's OK to have more
than 1 AE with DRUG
WITHDRAWN
Nov-15-2020 08:42:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Only 1 AE should
have DRUG
WITHDRAWN as
Action Taken. Please
have the PI decide
which one would be
the most appropriate.
Nov-11-2020 14:03:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate DM: Do not issue
query. Sending to
Triad team for CRA
assistance.
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916345
Page 158 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-11-2020 08:44:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 3: Answered As written. Both AEs
have the same start
and stop date/time.
Designating one AE to
be DRUG
WITHDRAWN as the
LATEST ACTION
TAKEN WITH
STUDY DRUG and
the other as NOT
APPLICABLE would
be arbitrary at best.
Nov-10-2020 19:13:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY Primary
Adverse Event.
Nov-10-2020 19:12:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed issued in error
Nov-10-2020 18:27:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Only one primary
Adverse Event should
be chosen to have
question 'Did the
adverse event cause
the subject to be
discontinued from the
study? answered as
YES if applicable.
Please chose Primary
Adverse Event.
Oct-20-2020 12:25:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Oct-20-2020 08:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 1: Answered Changed data per
query
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916346
Page 159 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-19-2020 12:49:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: Reason
for EOT is entered as
OTHER. If these
adverse events led to
the decision to
withdraw from
treatment, then EOT
should match with
reason ADVERSE
EVENT
Oct-19-2020 08:20:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 1: Answered Changed data per
query
Oct-19-2020 04:50:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Lightheadedness and
nausea are reported to
lead to 'Drug
Withdrawn'. If these
entries are correct, and
subject will not go on
to receive Vaccination
2 due to these events,
then please complete
the EOT tab to
indicate treatment
discontinuation.
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916347
Page 160 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 16:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916348
Page 161 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
nauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/23/2020 12:40Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date Time:
Sep/23/2020 14:40Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916349
Page 162 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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).
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
05:19:12
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Clo
sedSTAT, SPA
confirmed it's OK to
have more than 1
AE with DRUG
WITHDRAWN
Nov-15-2020
08:42:19
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Rei
ssued:Opene
dOnly 1 AE should
have DRUG
WITHDRAWN as
Action Taken.
Please have the PI
decide which one
would be the most
appropriate.
Nov-11-2020
14:03:47ACV0PFEINFP6000  Query 3: Rei
ssued:CandidDM: Do not issue
query. Sending to
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916350
Page 163 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time
(US & Canada)ate Triad team for CRA
assistance.
Nov-11-2020
08:44:45
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 3: Ans
weredAs written. Both
AEs have the same
start and stop
date/time.
Designating one AE
to be DRUG
WITHDRAWN as
the LATEST
ACTION TAKEN
WITH STUDY
DRUG and the
other as NOT
APPLICABLE
would be arbitrary
at best.
Nov-10-2020
19:14:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 3: Op
enedOnly one primary
Adverse Event
should be chosen to
have question
'LATEST ACTION
TAKEN WITH
STUDY DRUG'
that would indicate
DRUG
WITHDRAWN.
Multiple are
selected at this time,
please select ONLY
Primary Adverse
Event.
Nov-10-2020
19:13:44
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clo
sedissued in error
Nov-10-2020
18:28:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Op
enedOnly one primary
Adverse Event
should be chosen to
have question 'Did
the adverse event
cause the subject to
be discontinued
from the study?
answered as YES if
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916351
Page 164 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
applicable. Please
chose Primary
Adverse Event.
Oct-20-2020
12:39:22
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Clo
sedAuto closed by
Validation Check:
VC_AE001_32
Oct-20-2020
08:32:21
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 1: Ans
weredChanged data per
query
Oct-19-2020
20:50:27
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Op
enedDMW5068940;The
Latest Action to
Study Treatment is
DRUG
WITHDRAWN, but
the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Oct-16-2020
16:03:54
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
DRUG WIT
HDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916352
Page 165 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 16:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916353
Page 166 of 179
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 10:02:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-11-2020 08:36:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-11-2020 08:36:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Sep/23/2020Changed Information
Nov-10-2020 18:29:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The discontinuation
date of 14OCT2020
should be relative to
the AE causing the the
withdrawal of the
study vaccine, AE
start 23SEP2020 and
end 23SEP2020.
Please adjust
Discontinuation date.
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 07:01:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Not required.
Oct-20-2020 08:32:01
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Steven Choi Query 2: Answered As written. Pt is still
in study, but refused
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916354
Page 167 of 179
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) VAX2 and the NP
swab. Moreover,
saying that "the
adverse event caused
the pt to discontinue
study treatment"
would be more
accurate.
Oct-20-2020 08:29:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 08:29:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Oct-20-2020 08:29:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-20-2020 08:29:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
ADVERSE EVENTChanged Information
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-20-2020 08:29:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription Error
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt refused the 2nd vaccine and NP sw
ab, but is willing to come for future st
udy visits.Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916355
Page 168 of 179
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 08:14:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription Error
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 08:14:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 12:53:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 2: Closed Response satisfies
query
Oct-21-2020 08:14:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 2: Answered Changed data per
query
Oct-21-2020 03:22:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 2: Reissued:Opened CLINQUERY: Thanks
for the update - to
'remove' the date on
this field: if you
cannot remove the
date, consider applying
a 'not applicable'
comment to that field
for now
Oct-20-2020 13:42:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916356
Page 169 of 179
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020 13:42:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-20-2020 13:42:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry: Transcription Error
Oct-20-2020 13:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status" is
OTHER but "Specify
Status" is missing.
Oct-20-2020 10:03:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 2: Opened CLINQUERY: Per
information provided,
subject will continue
on in study (just
discontinued from
treatment). if that is
correct, please leave
this FUP tab blank to
indicate subject will
continue with follow
up
Oct-19-2020 08:18:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
OTHERTranscription Error
Oct-16-2020 16:01:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status" is
WITHDRAWAL BY
SUBJECT but
"Specify Status" is
missing.
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-20-2020 13:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription Error
Oct-19-2020 08:18:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt refused the 2nd vaccine and NP sw
ab, but is willing to come for future stTranscription Error
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916357
Page 170 of 179
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
udy visits.
Oct-16-2020 16:01:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Pt withdrew consent for personal reas
ons.Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916358
Page 171 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021 09:03:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Jan/20/2021Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916359
Page 172 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-22-2021 10:00:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-22-2021 09:03:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-22-2021 09:03:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have re
ceived only placebo at Vaccination
1/2Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916360
Page 173 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-22-2021 10:00:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Jan/20/2021Initial Entry
Feb-22-2021 09:59:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry: Initial Entry
Oct-23-2020 17:34:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Closed Response satisfies
query
Oct-23-2020 08:32:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 1: Answered Changed data per
query
Oct-23-2020 08:32:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Not ApplicableInitial Entry
Oct-21-2020 23:36:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly consider
to update this form if
require else mark as
Not applicable by
selecting form level
comment. Thank
you.
Oct-20-2020 13:41:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry: Initial Entry
Oct-20-2020 13:41:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Not DoneInitial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-22-2021 10:00:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
Feb-22-2021 09:59:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916361
Page 174 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-23-2020 08:32:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
Oct-20-2020 13:41:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Initial Entry
Oct-20-2020 13:41:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not DoneInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916362
Page 175 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Oct-23-2020 17:34:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Erica Weaver Query 2: Closed Response satisfies
query
Oct-23-2020 08:32:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Query 2: Answered Changed data per
query
Oct-23-2020 08:32:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
Not ApplicableInitial Entry
Oct-21-2020 23:47:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Kindly consider
to update this form if
require else mark as
Not applicable by
selecting form level
comment. Thank you.
Oct-20-2020 14:16:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Oct-20-2020 13:41:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-20-2020 13:41:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven Choi Data Entry: Transcription Error
Oct-20-2020 10:05:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: WOC
is reported as 14Oct20
yet information
suggests subject will
remain in study for
follow up
(discontinued from
treatment). Please
review since this
WOC matches to
withdrawal of consent
to participate in the
study overall
Oct-16-2020 15:59:45 ACV0PFEINFP6000  Steven Choi Data Entry: Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916363
Page 176 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific Time
(US & Canada)Oct/14/2020
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916364
Page 177 of 179
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020 13:42:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-20-2020 08:29:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-19-2020 08:18:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-24-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-24-2020 08:05:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 08:36:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020Changed Information
Oct-21-2020 08:14:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Transcription Error
Oct-20-2020 13:42:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Transcription Error
Oct-20-2020 08:29:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Changed Information
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916365
Page 178 of 179
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-19-2020 08:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Oct-19-2020 08:18:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Transcription Error
Oct-16-2020 16:00:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Sep-24-2020 08:14:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
Sep-24-2020 08:05:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916366
Page 179 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541186 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-05-2020 12:02:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Click Here to EnableInitial Entry
090177e196ae30d5\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916367