Document text
Page 1 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806610
Page 2 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/19/2020
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806611
Page 3 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11341432]
2.Birth Date: /1958
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806612
Page 4 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806613
Page 5 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806614
Page 6 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806615
Page 7 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[gout]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[perirectal abscess]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806616
Page 8 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right broken ankle]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[abscess surgery]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right ankle surgery]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806617
Page 9 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806618
Page 10 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [236.8]
3.Unit: LB
4.Height: [75.5]
5.Unit: in
6.Body Mass Index: [29.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806619
Page 11 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270252]
3.Randomization Group: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806620
Page 12 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BRBYBT]
5.bSample ID [BLG03S]
5.cSample ID [BLG05T]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806621
Page 13 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BM91JF]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806622
Page 14 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/19/2020 11:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806623
Page 15 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806624
Page 16 of 142
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806625
Page 17 of 142
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806626
Page 18 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCWJ2]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806627
Page 19 of 142
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: Nov/11/2020 10:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806628
Page 20 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806629
Page 21 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCWR6]
5.bSample ID [BSMS50]
5.cSample ID [BSMS3B]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806630
Page 22 of 142
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806631
Page 23 of 142
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806632
Page 24 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806633
Page 25 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806634
Page 26 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806635
Page 27 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806636
Page 28 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806637
Page 29 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806638
Page 30 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806639
Page 31 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806640
Page 32 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806641
Page 33 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806642
Page 34 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806643
Page 35 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806644
Page 36 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806645
Page 37 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806646
Page 38 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 HEROINE O
VERDOSE Nov/26/2020
UNK:UNK NO
End Date Time:
Nov/28/2020 UN
K:UNK
Repeating
Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806647
Page 39 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[HEROINE OVERDOSE]
4.Start Date Time: Nov/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/28/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806648
Page 40 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[SUBSTANCE ABUSE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806649
Page 41 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020487850]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806650
Page 42 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806651
Page 43 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806652
Page 44 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO FLU VACC
INE Nov/28
/2020 Repeating
Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806653
Page 45 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[FLU VACCINE]
5.Date: Nov/28/2020
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806654
Page 46 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806655
Page 47 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806656
Page 48 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806657
Page 49 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806658
Page 50 of 142
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806659
Page 51 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806660
Page 52 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806661
Page 53 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806662
Page 54 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806663
Page 55 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806664
Page 56 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806665
Page 57 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806666
Page 58 of 142
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806667
Page 59 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806668
Page 60 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806669
Page 61 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806670
Page 62 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806671
Page 63 of 142
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806672
Page 64 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806673
Page 65 of 142
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806674
Page 66 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806675
Page 67 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806676
Page 68 of 142
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806677
Page 69 of 142
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806678
Page 70 of 142
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/9/2020
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806679
Page 71 of 142
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806680
Page 72 of 142
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jonathan
Wilson Approved Feb-12-2021 15:52:43 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JonathanWilson, 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.
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806681
Page 73 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-19-2020 16:06:35
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806682
Page 74 of 142
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jonathan
Wilson Approved Feb-12-2021 15:52:43 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JonathanWilson, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-11-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Jan-25-2021 15:55:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806683
Page 75 of 142
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, JonathanWilson, 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.
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806684
Page 76 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020
16:02:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020
16:02:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHO
RTSInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806685
Page 77 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020
16:02:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Oct/19/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806686
Page 78 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020
16:01:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11341432Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020
16:01:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1958Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020
16:04:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806687
Page 79 of 142
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-19-2020
16:04:40
(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
Oct-19-2020
16:04:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFR
ICAN AMERICA
NInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806688
Page 80 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
16:06:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806689
Page 81 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020
16:07:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
16:07:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
16:07:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806690
Page 82 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020
16:13:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:13:07
(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
Oct-19-2020
16:13:07
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806691
Page 83 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
1.a Start Date:
Date Location User Value Reason
Oct-19-2020
16:13:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020
16:13:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020
16:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:gout
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806692
Page 84 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:13:41
(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
Oct-19-2020
16:13:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
goutInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020
16:13:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020
16:13:41ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806693
Page 85 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US & Canada)
1.c
Date Location User Value Reason
Oct-19-2020
16:14:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:perirectal a
bscess
Start Date
:UNK/UN
K/2000
Ongoing: NO
End Date
:
UNK/U
NK/200
0Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806694
Page 86 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:14:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
16:14:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
perirectal abscessInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020
16:14:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020
16:14:50ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806695
Page 87 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US & Canada)End Date:
UNK/UNK/20
00
1.d
Date Location User Value Reason
Oct-19-2020
16:17:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:right broke
n ankle
Start Date
:UNK/UN
K/2000
Ongoing: NO
End Date
:
UNK/U
NK/200
0Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806696
Page 88 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:17:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
16:17:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
right broken ankleInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020
16:17:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020
16:17:02ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806697
Page 89 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US & Canada)End Date:
UNK/UNK/20
00
1.e
Date Location User Value Reason
Oct-19-2020
16:19:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:abscess sur
gery
Start Date
:UNK/UN
K/2000
Ongoing: NO
End Date
:
UNK/U
NK/200
0Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806698
Page 90 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:19:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
16:19:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
abscess surgeryInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020
16:19:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020
16:19:14ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806699
Page 91 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US & Canada)End Date:
UNK/UNK/20
00
1.f
Date Location User Value Reason
Oct-19-2020
16:22:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:right ankle
surgery
Start Date
:UNK/UN
K/2000
Ongoing: NO
End Date
:
UNK/U
NK/200
0Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806700
Page 92 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020
16:22:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
16:22:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
right ankle surger
yInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020
16:22:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020
16:22:29ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806701
Page 93 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US & Canada)End Date:
UNK/UNK/20
00
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806702
Page 94 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020
16:12:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NO
T known to be HI
V POSITIVEInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806703
Page 95 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
236.8Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806704
Page 96 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
75.5Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.2Initial Entry
7.a
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.3Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806705
Page 97 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Temperat
ure Unit:F
Temperat
ure Locat
ion::FOR
EHE
AD
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806706
Page 98 of 142
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a Temperature Location:
Date Location User Value Reason
Oct-19-2020
16:10:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806707
Page 99 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020
16:10:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020
16:10:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
270252Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806708
Page 100 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
18:39:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
18:39:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
18:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
18:39:17
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806709
Page 101 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-19-2020
18:39:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
18:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRBYB
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
18:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRBYBTInitial Entry
5.b
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806710
Page 102 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-19-2020
18:39:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLG03
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
18:39:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLG03SInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
18:40:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLG05
TInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
18:40:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLG05TInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806711
Page 103 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
18:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
18:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
18:40:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
18:40:38
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806712
Page 104 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-19-2020
18:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
18:40:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BM91J
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
18:40:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM91JFInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806713
Page 105 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806714
Page 106 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020 11:0
7Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806715
Page 107 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-19-2020
16:11:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806716
Page 108 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020
16:11:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOG
ENICITY E-DIA
RY NOT COLLE
CTED FOR THIS
SUBJECTInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806717
Page 109 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-14-2020
02:20:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies
query
Nov-13-2020
10:33:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edThis has
been
updated!
Nov-13-2020
06:43:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete
‘Nasal Swab
form' at this
visit. Thank
you.
Nov-11-2020
17:34:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806718
Page 110 of 142
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2.a
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.1
Temperat
ure Unit:F
Temperat
ure Locat
ion::FOR
EHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806719
Page 111 of 142
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
2.a Temperature:
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-11-2020
17:34:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806720
Page 112 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020
10:31:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020
10:31:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020
10:32:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-13-2020
10:31:58
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806721
Page 113 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-13-2020
10:31:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020
10:32:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRCWJ
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020
10:32:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRCWJ2Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806722
Page 114 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806723
Page 115 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020 10:5
2Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806724
Page 116 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-11-2020
17:35:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806725
Page 117 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-14-2020
01:51:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Dec-11-2020
10:30:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dupdated
Dec-11-2020
07:36:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806726
Page 118 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
EOT to match
date of visit at
visit 3.
Dec-09-2020
16:03:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806727
Page 119 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020
15:29:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-09-2020
15:29:05
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806728
Page 120 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-09-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020
15:29:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRCW
R6Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-09-2020
15:29:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRCWR6Initial Entry
5.b
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806729
Page 121 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Dec-09-2020
15:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSMS5
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-09-2020
15:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSMS50Initial Entry
5.c
Date Location User Value Reason
Dec-09-2020
15:30:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSMS3
BInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806730
Page 122 of 142
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Dec-09-2020
15:30:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSMS3BInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806731
Page 123 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806732
Page 124 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-09-2020
16:09:28
(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
Dec-11-2020
17:50:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Dec-11-2020
10:22:02
(UTC-05:00)ACV0PFEINFP6000 Query 1: Answer
edmedical records
have been
requested
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806733
Page 125 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US & Canada)
Dec-11-2020
09:22:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened CLINICAL_
AER#2020487850
_ In the report
submitted to
safety, further
information on
clinical
presentation and
hospital course of
the event is
missing. Kindly
submit a FU
report with
additional details.
Thank you.
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEROINE OVE
RDOSEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/26/2020 UNK:U
NKInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806734
Page 126 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/28/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
4Initial 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
Dec-11-2020
08:03:41
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806735
Page 127 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
Dec-09-2020
16:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto
Query
Dec-09-2020
16:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalization
?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?Transcription
Error
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806736
Page 128 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
NO
Is this serious even
t life threatening?
YES
Other medically i
mportant serious e
vent
NO
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?'
is reported
'Yes', but at
least one
seriousness
criteria is
missing. Please
review and
update as
appropriate.
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
HEROINE
OVERDOSE:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806737
Page 129 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
blank.
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalization
?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
YESInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806738
Page 130 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
Dec-09-2020
16:09:28
(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
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
SUBSTANCE
ABUSEInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806739
Page 131 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-09-2020
16:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806740
Page 132 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Dec-09-2020
16:09:28
(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
Dec-11-2020
08:03:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020487850Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806741
Page 133 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806742
Page 134 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806743
Page 135 of 142
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FLU VACCINEInitial Entry
5. Date:
Date Location User Value Reason
Dec-11-2020
10:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806744
Page 136 of 142
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-11-2020
10:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-11-2020
10:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-11-2020
10:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806745
Page 137 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
12:21:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806746
Page 138 of 142
***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, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-11-2021
12:21:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed
to have receive
d only placebo
at Vaccination
1/2Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806747
Page 139 of 142
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-11-2021
12:20:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-11-2021
12:20:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCI
NATIONInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806748
Page 140 of 142
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-11-2020
10:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-19-2020
16:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-19-2020
16:07:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-11-2020
10:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2020Initial Entry
Oct-19-2020
16:10:49ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806749
Page 141 of 142
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-19-2020
16:07:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806750
Page 142 of 142
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-25-2021
15:24:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3012\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806751