125742 S1 M5 CRF c4591001 1054 10541173

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
427
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915762
Page 2 of 427
***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: 10541173 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/18/2020
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915763
Page 3 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10541173]
2.Birth Date: /1961
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0915764
Page 4 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915765
Page 5 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915766
Page 6 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915767
Page 7 of 427
***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: 10541173 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:[appendectomy]
Start Date: May/UNK/2005
Ongoing: NO
End Date:
May/UNK/2005
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: May/UNK/2005
Ongoing: NO
End Date:
May/UNK/2005
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[abdominal scar]
Start Date: May/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral lower legs edema 1+]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915768
Page 8 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral fungus toenails]
Start Date: UNK/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nerve pain, cervical spine]
Start Date: Sep/11/2020
Ongoing: YES
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915769
Page 9 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915770
Page 10 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [88.64]
3.Unit: kg
4.Height: [172.72]
5.Unit: cm
6.Body Mass Index: [29.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915771
Page 11 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [261406]
3.Randomization Group: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915772
Page 12 of 427
***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: 10541173 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/18/2020
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 [BM983G]
5.bSample ID [BM983H]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915773
Page 13 of 427
***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: 10541173 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/18/2020
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 [BM983J]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915774
Page 14 of 427
***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: 10541173 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/18/2020 11:50
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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915775
Page 15 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915776
Page 16 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915777
Page 17 of 427
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915778
Page 18 of 427
***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: 10541173 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:
Oct/9/2020
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 [BPYX1W]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915779
Page 19 of 427
***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: 10541173 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: Oct/9/2020 11:22
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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915780
Page 20 of 427
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915781
Page 21 of 427
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915782
Page 22 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915783
Page 23 of 427
***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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915784
Page 24 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915785
Page 25 of 427
***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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915786
Page 26 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915787
Page 27 of 427
***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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915788
Page 28 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915789
Page 29 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/20/2020
2.Date of First Symptom Started: Oct/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/UNK/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915790
Page 30 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915791
Page 31 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/28/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915792
Page 32 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/28/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [CLIA-certified laboratory] Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915793
Page 33 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10541173 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Swab was collected on site.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915794
Page 34 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10541173 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:
Oct/20/2020
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 [BM983Y]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915795
Page 35 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915796
Page 36 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915797
Page 37 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915798
Page 38 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915799
Page 39 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915800
Page 40 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915801
Page 41 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915802
Page 42 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915803
Page 43 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915804
Page 44 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915805
Page 45 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915806
Page 46 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915807
Page 47 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915808
Page 48 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915809
Page 49 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915810
Page 50 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915811
Page 51 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915812
Page 52 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915813
Page 53 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915814
Page 54 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915815
Page 55 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915816
Page 56 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915817
Page 57 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915818
Page 58 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915819
Page 59 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915820
Page 60 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915821
Page 61 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915822
Page 62 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915823
Page 63 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915824
Page 64 of 427
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10541173 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:
Feb/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMTKP]
5.bSample ID [BRMTKR]
5.cSample ID [BRMTKS]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915825
Page 65 of 427
***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: 10541173 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:
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915826
Page 66 of 427
***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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915827
Page 67 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915828
Page 68 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915829
Page 69 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  subacute bacterial e
ndocarditis Oct/28/2020 U
NK:UNK NO
End Date Time:
Dec/15/2020 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  pain L hamstring m
uscles Oct/28/2020 U
NK:UNK YES  Repeating
Pages
 3. ADVERSE
EVENT 3  subarachnoid hemo
rrhage Nov/5/2020 U
NK:UNK NO
End Date Time:
Nov/5/2020 UNK:U
NK
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  bacterial endocardit
is Oct/28/2020 U
NK:UNK YES  Repeating
Pages
 5. ADVERSE
EVENT 5  intermittent atrial fi
brillation Nov/6/2020 U
NK:UNK YES  Repeating
Pages
 6. ADVERSE
EVENT 6  acute aortic insuffic
iency Oct/28/2020 U
NK:UNK NO
End Date Time:
Dec/15/2020 UNK:
UNK
 Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915830
Page 70 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 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)[subacute bacterial endocarditis]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915831
Page 71 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[gram positive cocci, source unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020423609]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915832
Page 72 of 427
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 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)[pain L hamstring muscles]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[heavy lifting]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915833
Page 73 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915834
Page 74 of 427
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[subarachnoid hemorrhage]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/5/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915835
Page 75 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[possibly secondary to underlying bacterial endocarditis (mycotic
aneurysm)]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020423609]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915836
Page 76 of 427
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[bacterial endocarditis ]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[infection]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915837
Page 77 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915838
Page 78 of 427
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[intermittent atrial fibrillation]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[bacterial endocarditis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915839
Page 79 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915840
Page 80 of 427
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[acute aortic insufficiency]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915841
Page 81 of 427
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[subacute bacterial endocarditis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020423609]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915842
Page 82 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915843
Page 83 of 427
***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: 10541173 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[ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915844
Page 84 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915845
Page 85 of 427
***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: 10541173 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: //
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915846
Page 86 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915847
Page 87 of 427
***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: 10541173 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?
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915848
Page 88 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915849
Page 89 of 427
***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: 10541173 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?
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915850
Page 90 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915851
Page 91 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915852
Page 92 of 427
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/8/2021
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915853
Page 93 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915854
Page 94 of 427
***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: 10541173 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:
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915855
Page 95 of 427
***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: 10541173 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?
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915856
Page 96 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915857
Page 97 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915858
Page 98 of 427
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915859
Page 99 of 427
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915860
Page 100 of 427
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915861
Page 101 of 427
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10541173 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 [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915862
Page 102 of 427
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915863
Page 103 of 427
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915864
Page 104 of 427
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915865
Page 105 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915866
Page 106 of 427
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915867
Page 107 of 427
***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: 10541173 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: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915868
Page 108 of 427
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915869
Page 109 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915870
Page 110 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915871
Page 111 of 427
***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: 10541173 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: [ ]
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915872
Page 112 of 427
***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: 10541173 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 Feb/8/2021
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915873
Page 113 of 427
***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: 10541173 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
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915874
Page 114 of 427
***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: 10541173 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
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FDA-CBER-2021-5683-0915875
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Header Text: c4591001
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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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 13:35:30 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915876
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***Confidential***
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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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-02-2021 08:17:51 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915877
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-02-2021 08:17:51 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915878
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-02-2021 08:17:51 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915879
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Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-04-2021 12:05:57 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-04-2021 12:05:57 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-04-2021 12:05:57 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-04-2021 12:05:57 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-04-2021 12:05:57 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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FDA-CBER-2021-5683-0915884
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
FormOct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
1Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
2Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
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FDA-CBER-2021-5683-0915887
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
3Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915888
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
4Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
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FDA-CBER-2021-5683-0915889
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
5Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
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FDA-CBER-2021-5683-0915890
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
6Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
7Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915892
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
8Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915893
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Nov-05-2020 14:38:47 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi
9Oct-21-2020 16:10:31 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Done
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915894
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915895
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915896
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915897
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915899
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915900
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-21-2020 16:11:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915901
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-21-2020 16:12:58 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915902
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-21-2020 16:12:58 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915903
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-21-2020 16:12:58 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915904
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-21-2020 16:12:58 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0915905
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-21-2020 16:12:58 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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FDA-CBER-2021-5683-0915906
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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FormOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
1Oct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0915908
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915918
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915919
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915920
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915921
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915922
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915923
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915924
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915925
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915926
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915927
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915928
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915929
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915930
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915931
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915932
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915933
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915934
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915935
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0915936
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915937
Page 177 of 427
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
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Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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5.gOct-21-2020 16:13:15 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.aOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.aOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.aOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.aOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.bOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
5.bOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
5.bOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.bOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
5.cOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
5.dOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
5.dOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.dOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.eOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.eOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Subject No: 10541173 Subject Initials: ---
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.gOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.gOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915970
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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5.gOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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FDA-CBER-2021-5683-0915971
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.gOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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Back to Form
ItemDate User Comment
5 hOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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FDA-CBER-2021-5683-0915973
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 hOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-21-2020 16:13:33 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
FormOct-21-2020 16:13:52 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
2.aOct-21-2020 16:13:52 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
2.aOct-21-2020 16:13:52 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Subject No: 10541173 Subject Initials: ---
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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Subject No: 10541173 Subject Initials: ---
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
1Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916002
Page 242 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916003
Page 243 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-21-2020 16:14:41 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916004
Page 244 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-21-2020 16:14:55 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916005
Page 245 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-21-2020 16:14:55 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916006
Page 246 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-21-2020 16:14:55 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916007
Page 247 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-21-2020 16:14:55 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916008
Page 248 of 427
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-21-2020 16:14:55 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916009
Page 249 of 427
***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: 10541173 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 Nov-19-2020 13:16:31 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Nov-16-2020 16:08:51 (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-16-2020 11:52:13 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Nov-16-2020 10:55:49 (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.
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916010
Page 250 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Steven Choi  N/A Nov-16-2020 09:13:44 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Nov-11-2020 10:08:52 (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-05-2020 13:11:06 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Nov-03-2020 14:34:45 (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-03-2020 08:19:42 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916011
Page 251 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mark
Leibowitz Approved Nov-02-2020 14:14:59 (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-02-2020 11:42:11 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Nov-02-2020 07:49:08 (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 Oct-30-2020 14:56:35 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Oct-30-2020 14:27:57 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916012
Page 252 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916013
Page 253 of 427
***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: 10541173 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-18-2020 13:34:30
(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-18-2020 13:34:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916014
Page 254 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020 13:34:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
OBTAINED
Date Written Consent Obtained
Sep/18/2020Initial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916015
Page 255 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020 13:33:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10541173Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020 13:33:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020 13:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-18-2020 13:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-18-2020 13:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
WHITEInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916016
Page 256 of 427
***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: 10541173 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-18-2020 13:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/18/2020Initial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916017
Page 257 of 427
***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: 10541173 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-18-2020 13:35:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 13:35:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 13:35:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916018
Page 258 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020 13:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:appendectomy
Start Date: May/UNK/200
5
Ongoing: NO
End Date:
May/UNK/
2005Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:36:07
(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-18-2020 13:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
appendectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-18-2020 13:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
May/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916019
Page 259 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 13:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
May/UNK/2005Initial Entry
1.b
Date Location User Value Reason
Sep-18-2020 13:36:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:appendicitis
Start Date: May/UNK/200
5
Ongoing: NO
End Date:
May/UNK/
2005Initial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916020
Page 260 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:36:36
(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-18-2020 13:36:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
appendicitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020 13:36:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
May/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020 13:36:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
May/UNK/2005Initial Entry
1.c
Date Location User Value Reason
Sep-18-2020 13:44:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:abdominal sc
ar
Start Date: May/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916021
Page 261 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:44:30
(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-18-2020 13:44:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
abdominal scarInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-18-2020 13:44:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
May/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-18-2020 13:44:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-18-2020 13:45:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:bilateral lower leg
s edema 1+
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916022
Page 262 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:45:05
(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-18-2020 13:45:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
bilateral lower legs edema 1+Initial Entry
1.d Start Date:
Date Location User Value Reason
Sep-18-2020 13:45:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-18-2020 13:45:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-18-2020 13:45:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:bilateral fungus
toenails
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916023
Page 263 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:45:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:45:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
bilateral fungus toenailsInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-18-2020 13:45:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-18-2020 13:45:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-10-2020 13:29:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:nerve pain, cervi
cal spine
Start Date: Sep/11/2020
Ongoing: YESInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916024
Page 264 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Nov-10-2020 13:29:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-10-2020 13:29:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
nerve pain, cervical spineInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-10-2020 13:29:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/11/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-10-2020 13:29:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916025
Page 265 of 427
***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: 10541173 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-18-2020 13:36:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916026
Page 266 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
88.64Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
172.72Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) PacificACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.7Initial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916027
Page 267 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Record Identifier:
:1
Temperature: 97.6
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 13:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916028
Page 268 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020 13:39:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020 13:39:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
261406Initial Entry
090177e196ae30e5\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0916029
Page 269 of 427
***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: 10541173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:39:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:39:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 15:34:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 13:39:52
(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-18-2020 13:39:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 15:34:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BM983GInitial Entry
090177e196ae30e5\Final\Final On: 
…[truncated]
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