Document text
Page 1 of 122
***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: 11621276 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
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843428
Page 2 of 122
***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: 11621276 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
Sep/3/2020
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843429
Page 3 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11621276]
2.Birth Date: /1964
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843430
Page 4 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843431
Page 5 of 122
***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: 11621276 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
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843432
Page 6 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843433
Page 7 of 122
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
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: 11621276 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:[Farsighted]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Overweight]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.dLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843434
Page 8 of 122
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [104.9]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [35.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843435
Page 9 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [251194]
3.Randomization Group: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843436
Page 10 of 122
***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: 11621276 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:
Sep/3/2020
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 [BP8CTP]
5.bSample ID [BP8CTR]
5.cSample ID [BP8CTS]
5.dSample ID [BLCLR5]
5.eSample ID [BLCLR6]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843437
Page 11 of 122
***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: 11621276 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/3/2020
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 [BP8CTN]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843438
Page 12 of 122
***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: 11621276 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/3/2020 12:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843439
Page 13 of 122
***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: 11621276 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
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843440
Page 14 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843441
Page 15 of 122
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843442
Page 16 of 122
***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: 11621276 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/25/2020
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 [BR8S46]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843443
Page 17 of 122
***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: 11621276 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/25/2020 11:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843444
Page 18 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843445
Page 19 of 122
***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: 11621276 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/26/2020
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 [BR8SJC]
5.bSample ID [BS744S]
5.cSample ID [BS744R]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843446
Page 20 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843447
Page 21 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 11621276 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:
Mar/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8Z34]
5.bSample ID [BS4NX8]
5.cSample ID [BS4NXJ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843448
Page 22 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843449
Page 23 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843450
Page 24 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843451
Page 25 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843452
Page 26 of 122
***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: 11621276 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:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843453
Page 27 of 122
***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: 11621276 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: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843454
Page 28 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843455
Page 29 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843456
Page 30 of 122
***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: 11621276 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?
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843457
Page 31 of 122
***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: 11621276 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:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843458
Page 32 of 122
***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: 11621276 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:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843459
Page 33 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843460
Page 34 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843461
Page 35 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843462
Page 36 of 122
***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: 11621276 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843463
Page 37 of 122
***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: 11621276 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: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843464
Page 38 of 122
***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: 11621276 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:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843465
Page 39 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843466
Page 40 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 myocardial infar
ction Nov/10/2020 UNK:
UNK NO
End Date Time:
Nov/12/2020 UNK:UNK
Repeating
Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843467
Page 41 of 122
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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)[myocardial infarction]
4.Start Date Time: Nov/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/12/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843468
Page 42 of 122
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[coronary artery disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021253747]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843469
Page 43 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843470
Page 44 of 122
***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: 11621276 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[ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843471
Page 45 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843472
Page 46 of 122
***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: 11621276 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: //
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843473
Page 47 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843474
Page 48 of 122
***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: 11621276 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?
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843475
Page 49 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843476
Page 50 of 122
***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: 11621276 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?
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843477
Page 51 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843478
Page 52 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843479
Page 53 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843480
Page 54 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843481
Page 55 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11621276 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?
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843482
Page 56 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843483
Page 57 of 122
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843484
Page 58 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843485
Page 59 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843486
Page 60 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843487
Page 61 of 122
***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: 11621276 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 [ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843488
Page 62 of 122
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843489
Page 63 of 122
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843490
Page 64 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843491
Page 65 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843492
Page 66 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843493
Page 67 of 122
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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/26/2020
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843494
Page 68 of 122
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843495
Page 69 of 122
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843496
Page 70 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-04-2020 14:19:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4
(b) (4)
FDA-CBER-2021-5683-0843497
Page 71 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-09-2021 16:08:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843498
Page 72 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-09-2021 16:08:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843499
Page 73 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-10-2021 17:45:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843500
Page 74 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-10-2021 17:45:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843501
Page 75 of 122
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-09-2021 16:08:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-03-2020 17:03:54 (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.
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843502
Page 76 of 122
***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: 11621276 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
Sep-04-2020 14:16:08
(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
Sep-04-2020 14:16:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843503
Page 77 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 14:16:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843504
Page 78 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 14:15:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11621276Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 14:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843505
Page 79 of 122
***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: 11621276 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-04-2020 14:19:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843506
Page 80 of 122
***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: 11621276 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
Sep-04-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843507
Page 81 of 122
***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, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 14:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Farsighted
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:21:39
(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
Sep-04-2020 14:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FarsightedInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 14:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 14:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843508
Page 82 of 122
***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, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Sep-04-2020 14:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Overweight
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:22:11
(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
Sep-04-2020 14:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OverweightInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020 14:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020 14:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843509
Page 83 of 122
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
104.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.0Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843510
Page 84 of 122
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843511
Page 85 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 14:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020 14:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
251194Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843512
Page 86 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 14:25:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 14:25:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:25:33
(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 and correct
as appropriate.
Sep-04-2020 14:25:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8CTPInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843513
Page 87 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8CTPInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 14:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8CTRInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020 14:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8CTRInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 14:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8CTSInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020 14:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8CTSInitial Entry
5.d
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCLR5Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843514
Page 88 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCLR5Initial Entry
5.e
Date Location User Value Reason
Sep-04-2020 14:27:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCLR6Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-04-2020 14:27:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCLR6Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843515
Page 89 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 14:27:39
(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-04-2020 14:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:27:39
(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 and correct
as appropriate.
Sep-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8CTNInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843516
Page 90 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 14:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8CTNInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843517
Page 91 of 122
***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: 11621276 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-04-2020 14:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 14:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 14:29:27
(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-04-2020 14:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 12:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 14:29:27
(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-04-2020 14:29:27
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843518
Page 92 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-04-2020 14:29:27
(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
Sep-04-2020 14:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 14:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843519
Page 93 of 122
***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: 11621276 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
Sep-04-2020 14:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843520
Page 94 of 122
***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: 11621276 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-28-2020 11:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843521
Page 95 of 122
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843522
Page 96 of 122
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-28-2020 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843523
Page 97 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 11:43:36
(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-28-2020 11:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 11:43:36
(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 and correct
as appropriate.
Sep-28-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 11:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8S46Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843524
Page 98 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 11:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8S46Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843525
Page 99 of 122
***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: 11621276 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-28-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 11:44:37
(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-28-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 11:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 11:44:37
(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-28-2020 11:44:37
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843526
Page 100 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-28-2020 11:44:37
(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
Sep-28-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843527
Page 101 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020 15:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843528
Page 102 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 15:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 15:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 10:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-27-2020 04:42:06
(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.
Oct-26-2020 15:12:10
(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 and correct
as appropriate.
Oct-26-2020 15:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843529
Page 103 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Oct-27-2020 10:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8SJCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 10:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8SJCInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 10:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS744SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 10:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS744SInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 10:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS744RInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 10:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS744RInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843530
Page 104 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 01:09:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation_PD
tracker updated
Mar-11-2021 09:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data correct, site to
note PD
Mar-11-2021 04:11:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Date of visit at
V4_MONTH6_L is
out of window for
-14 days from
V2_VAX2_L DOV
or V2 Vaccination
date. Please verify
and update. Else,
confirm in query
response
appropriately.
Mar-09-2021 16:08:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843531
Page 105 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 17:44:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 17:44:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 17:44:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 17:44:22
(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 and correct
as appropriate.
Mar-10-2021 17:44:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 17:44:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8Z34Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843532
Page 106 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 17:44:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8Z34Initial Entry
5.b
Date Location User Value Reason
Mar-10-2021 17:44:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS4NX8Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021 17:44:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS4NX8Initial Entry
5.c
Date Location User Value Reason
Mar-10-2021 17:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS4NXJInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843533
Page 107 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User ValueReason
Mar-11-2021
22:42:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Mar-11-2021
16:26:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Mar-11-2021
16:22:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Barcode
BS4NXJ is also
recorded for subject
11621325 V101.
Please review for
both subjects and
correct where
appropriate.
Otherwise please
clarify.
Mar-11-2021
09:35:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Mar-11-2021
04:14:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7669124;This
Barcode appears to
be already recorded
within the study.
Please review and
update as
appropriate.
Mar-10-2021
17:45:19
(UTC-05:00)ACV0PFEINFP6000 Data
Entry
:Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843534
Page 108 of 122
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US &
Canada)BS4N
XJ
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843535
Page 109 of 122
***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: 11621276 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-26-2020 15:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 15:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 15:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843536
Page 110 of 122
***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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843537
Page 111 of 122
***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, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 16:13:40
(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 Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
myocardial infarctionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843538
Page 112 of 122
***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, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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 Value Reason
Mar-09-2021 20:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE myocardial
infarction :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disabilityInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843539
Page 113 of 122
***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, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us 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
Mar-09-2021 16:13:40
(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
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
coronary artery diseaseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843540
Page 114 of 122
***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, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021 16:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-09-2021 20:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021253747Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843541
Page 115 of 122
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 16:09:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843542
Page 116 of 122
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-09-2021 16:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843543
Page 117 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-09-2021 16:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-09-2021 16:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843544
Page 118 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Mar-09-2021 16:08:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843545
Page 119 of 122
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
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: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-10-2021 17:45:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843546
Page 120 of 122
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-11-2021 07:13:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Clinical_Pls revise=
1]Subject has a
MedHx of HTN and
ADHD ((Per report
AER#
2021253747),
kindly review
MEDHX form and
update accordingly.
2]Subject has BMI=
>35, kindly revise
for correct term of
condition recorded
in MedHx
_overweight vs
obesity.
Oct-26-2020 15:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020 14:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-09-2021 20:37:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-09-2021 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered data updated; AE added
090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843547
Page 121 of 122
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-09-2021 06:21:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021253747
heart attack(onset
date:10Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-26-2020 15:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
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Time (US & Canada)ACV0PFEINFP6000 auto calc
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Time (US & Canada)ACV0PFEINFP6000 auto calc
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090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843548
Page 122 of 122
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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1. Casebook Signature
Date Location User Value Reason
Nov-03-2020 15:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
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090177e196ae2f8c\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843549