125742 S1 M5 CRF c4591001 1162 11621128

Document text

Page 1 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843290
Page 2 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843291
Page 3 of 138
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11621128]
2.Birth Date: /1983
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843292
Page 4 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843293
Page 5 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843294
Page 6 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843295
Page 7 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gun shot wound]
Start Date: May/UNK/2016
Ongoing: NO
End Date:
May/UNK/2016
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Exploratory Abdominal Surgery]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843296
Page 8 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [111.5]
3.Unit: kg
4.Height: [177.0]
5.Unit: cm
6.Body Mass Index: [35.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843297
Page 9 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [52825]
3.Randomization Group: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843298
Page 10 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP3J7R]
5.bSample ID [BP3J7S]
5.cSample ID [BP3J7T]
5.dSample ID [BPLNYY]
5.eSample ID [BPLNYZ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843299
Page 11 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP3J7P]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843300
Page 12 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Aug/17/2020 13:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843301
Page 13 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843302
Page 14 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843303
Page 15 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843304
Page 16 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP8CZL]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843305
Page 17 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/9/2020 16:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843306
Page 18 of 138
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843307
Page 19 of 138
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BLFV5Z]
5.bSample ID [BLFV60]
5.cSample ID [BPYRPR]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843308
Page 20 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843309
Page 21 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843310
Page 22 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843311
Page 23 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843312
Page 24 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843313
Page 25 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843314
Page 26 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843315
Page 27 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843316
Page 28 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843317
Page 29 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843318
Page 30 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843319
Page 31 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843320
Page 32 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843321
Page 33 of 138
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843322
Page 34 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843323
Page 35 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843324
Page 36 of 138
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843325
Page 37 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843326
Page 38 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843327
Page 39 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843328
Page 40 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure during
pregnancy Sep/UNK/2020
UNK:UNK YES  Repeating
Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843329
Page 41 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Exposure during pregnancy]
4.Start Date Time: Sep/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
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
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843330
Page 42 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Pregnancy]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843331
Page 43 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843332
Page 44 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843333
Page 45 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843334
Page 46 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843335
Page 47 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843336
Page 48 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843337
Page 49 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843338
Page 50 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843339
Page 51 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843340
Page 52 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843341
Page 53 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843342
Page 54 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843343
Page 55 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843344
Page 56 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843345
Page 57 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843346
Page 58 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843347
Page 59 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843348
Page 60 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843349
Page 61 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843350
Page 62 of 138
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843351
Page 63 of 138
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843352
Page 64 of 138
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843353
Page 65 of 138
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843354
Page 66 of 138
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843355
Page 67 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843356
Page 68 of 138
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843357
Page 69 of 138
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Riesenberg Approved Nov-17-2020 08:08:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843358
Page 70 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-18-2020 11:00:59 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
Not Applicable
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843359
Page 71 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Nov-16-2020 08:51:29 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843360
Page 72 of 138
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Riesenberg Approved Nov-17-2020 08:08:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
 N/A Nov-16-2020 08:51:17 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-13-2020 14:08:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843361
Page 73 of 138
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
 N/A Nov-13-2020 11:39:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-10-2020 15:36:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
 N/A Nov-09-2020 18:11:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843362
Page 74 of 138
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
N/A
Robert
Riesenberg Approved Oct-23-2020 15:44:34 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843363
Page 75 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-18-2020
11:00:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020
11:00:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843364
Page 76 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020
11:00:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/17/2020Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843365
Page 77 of 138
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020
11:00:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11621128Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020
10:59:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1983Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020
11:00:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020
11:00:34ACV0PFEINFP6000  Data Entry:
NOT HISPANIC ORInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843366
Page 78 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)LATINO(A) OR OF
SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020
11:00:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843367
Page 79 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020
10:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Data updated as
per query.
Aug-20-2020
12:28:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
Aug-20-2020
06:01:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Randomization
date and
randomization
number
recorded at
Impala but not
recorded at
Inform. Please
review and
update data as
appropriate.
Else, clarify.
Thank you.
Aug-18-2020
11:00:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843368
Page 80 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843369
Page 81 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-18-2020
11:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020
11:01:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020
11:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843370
Page 82 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020
11:04:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Gun shot w
ound
Start Date: May/UNK/
2016
Ongoing: NO
End Date:
May/UN
K/2016Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020
11:04:12
(UTC-05:00)
Eastern 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
Aug-18-2020
11:04:12
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Gun shot woundInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843371
Page 83 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-18-2020
11:04:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020
11:04:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/UNK/2016Initial Entry
1.b
Date Location User Value Reason
Aug-18-2020
11:05:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Exploratory A
bdominal Sur
gery
Start Dat
e:UNK/UNK/20
16Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843372
Page 84 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Date:
UNK/UNK
/2016
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843373
Page 85 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020
11:05:14
(UTC-05:00)
Eastern 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
Aug-18-2020
11:05:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exploratory Abdomi
nal SurgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020
11:05:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020
11:05:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843374
Page 86 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) UNK/UNK/2016
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843375
Page 87 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
111.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843376
Page 88 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)177.0
5. Unit:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.6Initial Entry
7.a
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperatu
re:36.9
Temperatu
re Unit:CInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843377
Page 89 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843378
Page 90 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-18-2020
11:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843379
Page 91 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020
12:27:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020
12:27:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
52825Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843380
Page 92 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020
11:08:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
11:08:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
04:41:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-26-2020
14:47:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto
Query
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0843381
Page 93 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-21-2020
07:43:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedDM: The
barcode is not
entered in a
correct field.
To enter
barcode, Click
on Add Entry
button to add
individual
Sample ID
details. Please
follow section
"8.11.4.
Sample ID:" of
CRF-CR.
Aug-20-2020
12:26:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Aug-19-2020
09:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-18-2020
11:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843382
Page 94 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
and correct as
appropriate.
Aug-18-2020
11:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/17/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Aug-27-2020
04:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-26-2020
14:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Aug-26-2020
14:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Aug-21-2020
06:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM : Bar Code
needs to be
recorded in the
specified area
under Sample
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843383
Page 95 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ID. Please
consider
updating data in
the appropriate
field, Thank
you.
Aug-20-2020
12:26:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7R BP3J7S BP3
J7T BPLNYY BPLN
YZInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020
14:47:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3J7RInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
14:47:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7RInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843384
Page 96 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020
14:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3J7SInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020
14:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7SInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
14:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3J7TInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020
14:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7TInitial Entry
5.d
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843385
Page 97 of 138
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-26-2020
14:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLNYYInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020
14:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLNYYInitial Entry
5.e
Date Location User Value Reason
Aug-26-2020
14:48:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLNYZInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020
14:48:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLNYZInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843386
Page 98 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020
11:08:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
11:08:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
04:41:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-26-2020
14:49:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto
Query
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0843387
Page 99 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-21-2020
07:43:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedDM: The
barcode is not
entered in a
correct field.
To enter
barcode, Click
on Add Entry
button to add
individual
Sample ID
details. Please
follow section
"8.11.4.
Sample ID:" of
CRF-CR.
Aug-20-2020
12:26:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Aug-19-2020
09:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-18-2020
11:08:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843388
Page 100 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
and correct as
appropriate.
Aug-18-2020
11:08:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/17/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Aug-27-2020
04:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-26-2020
14:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Aug-26-2020
14:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Aug-21-2020
06:51:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM : Bar Code
needs to be
recorded in the
specified area
under Sample
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843389
Page 101 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ID. Please
consider
updating data in
the appropriate
field, Thank
you.
Aug-20-2020
12:26:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7PInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020
14:49:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3J7PInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
14:49:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3J7PInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843390
Page 102 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020
12:27:56ACV0PFEINFP6000  Data Entry:
Aug/17/2020 13:19Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843391
Page 103 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US &
Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843392
Page 104 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-20-2020
12:27:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843393
Page 105 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-18-2020
11:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843394
Page 106 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
15:35:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843395
Page 107 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 37.1
Temperature
Unit:C
Temperature
Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843396
Page 108 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
15:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843397
Page 109 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
15:37:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
15:37:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
15:37:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
15:37:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843398
Page 110 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and
correct as
appropriate.
Sep-10-2020
15:37:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
15:37:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8CZLInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
15:37:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8CZLInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843399
Page 111 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
15:38:08ACV0PFEINFP6000  Data Entry:
Sep/9/2020 16:33Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843400
Page 112 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843401
Page 113 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-10-2020
15:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843402
Page 114 of 138
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
02:10:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Nov-09-2020
18:13:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
AnsweredUpdated
Nov-08-2020
19:32:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020423445
pregnancy partner(onset
date:01Sep2020)was
reported in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Oct-14-2020
15:12:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
Oct/13/20
20Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843403
Page 115 of 138
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
15:17:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
15:17:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
15:17:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
15:17:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843404
Page 116 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and
correct as
appropriate.
Oct-14-2020
15:17:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
15:17:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLFV5ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
15:17:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLFV5ZInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020
15:17:33
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample ID: BLFV60Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843405
Page 117 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
15:17:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLFV60Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020
15:17:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYRPRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
15:17:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYRPRInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843406
Page 118 of 138
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
15:17:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
15:17:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
15:17:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843407
Page 119 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843408
Page 120 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Nov-18-2020
21:19:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedacceptable discrepancy
Nov-17-2020
19:55:46
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query
1: Rei
ssued:
CandiPending SDB update
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843409
Page 121 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US &
Canada)date
Nov-17-2020
17:20:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dConfirmed, updated report has
been submitted.
Nov-16-2020
15:37:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Open
edAEM = updated SAE form.
Please confirm if a follow up
AEM form was submitted to
update term in Safety database.
Nov-16-2020
15:03:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dPlease clarify what AEM form is.
Nov-14-2020
10:06:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Open
edSAE RECON 1: Thank you for
the update. Please confirm if a
follow up AEM form was
submitted to update term in
Safety database.
Nov-13-2020
11:39:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843410
Page 122 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-13-2020
11:39:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Expos
ure du
ring p
regna
ncyTranscription Error
Nov-13-2020
06:15:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020423445,event
term was reported as
PREGNANT PARTNER in both
database.As per V10 CRF CG
8.50.2.5 that the event should be
reported as "exposure during
pregnancy". Please confirm and
update accordingly.
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Pregn
ant pa
rtnerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843411
Page 123 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
15:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-16-2020
08:51:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-16-2020
08:51:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dChanged
Information
Nov-16-2020
08:51:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Nov-15-2020
01:39:09ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Toxicity grade is
not expected for
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843412
Page 124 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)pregnancy
related adverse
events, hence
please remove
the toxicity and
add item level
comment as
NOT
APPLICABLE.
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User ValueReason
Nov-14-2020
10:03:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
seddowngraded to non serious
Nov-13-2020
11:40:26
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Del
etedClose Auto Query
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843413
Page 125 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US &
Canada)
Nov-13-2020
11:40:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Ans
weredTranscription Error
Nov-13-2020
11:40:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NOTranscription Error
Nov-13-2020
11:39:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Can
didateFor AE Exposure during
pregnancy : Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Nov-10-2020
08:27:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ope
nedSAE RECON:
AER#2020423445,'PREGNANT
PARTNER', event was
appropriately reported to safety;
however, seriousness criteria is
met there is an abnormal
pregnancy outcome/protocol
section 8.3.5.1. Please update
seriousness criteria accordingly.
Nov-10-2020
08:26:54
(UTC-05:00)ACV0PFEINFP6000  Query
2: Del
etedQuery can be addressed
internally
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843414
Page 126 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US &
Canada)
Nov-09-2020
18:11:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Nov-09-2020
18:11:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES
Is thi
s seri
ous e
vent
assoc
iated
with
cong
enita
l ano
maly
or bi
rth d
efect
?
NO
Did t
his s
eriou
s eveTranscription Error
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843415
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***Confidential***
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Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
nt re
sult i
n dea
th?
NO
Did t
his s
eriou
s eve
nt re
quire
or pr
olon
g hos
pitali
zatio
n?
NO
Did t
his s
eriou
s eve
nt re
sult i
n per
siste
nt or
signi
fican
t disa
bility
/inca
pacit
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843416
Page 128 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
y?
NO
Is thi
s seri
ous e
vent
life t
hreat
enin
g?
NO
Othe
r me
dical
ly im
porta
nt se
rious
event
YE
S
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Can
didateFor AE Pregnant partner:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Nov-09-2020
18:11:14
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ope
ned'Is the adverse event serious?' is
marked as YES, but responses to
all of the seriousness criteria are
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843417
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US &
Canada)NO. At least one seriousness
criterion is expected to be YES
for serious events. Please review
and update as appropriate.
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES
Is thi
s seri
ous e
vent
assoc
iated
with
cong
enita
l ano
maly
or bi
rth d
efect
?
NO
Did t
his s
eriou
s eve
nt re
sult i
n dea
th?
NOInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843418
Page 130 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Did t
his s
eriou
s eve
nt re
quire
or pr
olon
g hos
pitali
zatio
n?
NO
Did t
his s
eriou
s eve
nt re
sult i
n per
siste
nt or
signi
fican
t disa
bility
/inca
pacit
y?
NO
Is thi
s seri
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843419
Page 131 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ous e
vent
life t
hreat
enin
g?
NO
Othe
r me
dical
ly im
porta
nt se
rious
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.
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-09-2020
18:11:14ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843420
Page 132 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
Pregnancy
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843421
Page 133 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-14-2020
10:04:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dResponse satisfies
query
Nov-13-2020
16:50:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dResponse satisfies
query
Nov-13-2020
11:44:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answ
eredChanged data per
query
Nov-13-2020
11:44:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dFor AE Exposure
during pregnancy :
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Nov-13-2020
11:44:02ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredChanged
Information
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843422
Page 134 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)
Nov-13-2020
11:44:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNChanged
Information
Nov-11-2020
05:43:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dSAE RECON:
AER#2020423445,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED.Based
on the latest EDP
guidance, outcome
should be recorded
as UNKNOWN.
Please confirm and
update accordingly.
Nov-09-2020
18:12:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVE
RED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-09-2020
18:11:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843423
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843424
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
15:17:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020
12:27:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Aug-18-2020
11:01:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020
15:17:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-20-2020
12:27:31
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843425
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Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada)
Aug-18-2020
11:01:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843426
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Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020
15:44:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f8e\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843427