Document text
Page 1 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806412
Page 2 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/6/2020
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806413
Page 3 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11341378]
2.Birth Date: /1980
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806414
Page 4 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806415
Page 5 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806416
Page 6 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806417
Page 7 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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:[hepatitis C]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806418
Page 8 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806419
Page 9 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
2.Weight: [224.4]
3.Unit: LB
4.Height: [67.5]
5.Unit: in
6.Body Mass Index: [34.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806420
Page 10 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/6/2020
2.Randomization Number: [99723]
3.Randomization Group: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806421
Page 11 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/6/2020
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 [BNVMJR]
5.bSample ID [BLG019]
5.cSample ID [BM9136]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806422
Page 12 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/6/2020
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 [BM91DM]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806423
Page 13 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/6/2020 10:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806424
Page 14 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806425
Page 15 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806426
Page 16 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806427
Page 17 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/27/2020
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 [BM91JR]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806428
Page 18 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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/27/2020 09:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806429
Page 19 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806430
Page 20 of 198
***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: 11341378 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:
Nov/24/2020
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 [BSMS0G]
5.bSample ID [BSMS0W]
5.cSample ID [BRCWN7]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806431
Page 21 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806432
Page 22 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806433
Page 23 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806434
Page 24 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806435
Page 25 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806436
Page 26 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806437
Page 27 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806438
Page 28 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/15/2021
2.Date of First Symptom Started: Jan/15/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/21/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806439
Page 29 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Symptoms - Other
5.aSymptoms - Other Text: [nausea]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806440
Page 30 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806441
Page 31 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806442
Page 32 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 11341378 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject did not call Marken for a pickup.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806443
Page 33 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: 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: 11341378 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SUBJECT DID THE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806444
Page 34 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806445
Page 35 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806446
Page 36 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806447
Page 37 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806448
Page 38 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806449
Page 39 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806450
Page 40 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806451
Page 41 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806452
Page 42 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806453
Page 43 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806454
Page 44 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806455
Page 45 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806456
Page 46 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806457
Page 47 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806458
Page 48 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806459
Page 49 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806460
Page 50 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806461
Page 51 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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.Start Date: //
6.Ongoing?
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806462
Page 52 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806463
Page 53 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806464
Page 54 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806465
Page 55 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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:
Feb/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BV094H]
5.bSample ID [BS1HHG]
5.cSample ID [BS1HJR]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806466
Page 56 of 198
***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: 11341378 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:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806467
Page 57 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806468
Page 58 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806469
Page 59 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806470
Page 60 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Bell's Palsy Nov/4/2020 UNK:U
NK NO
End Date Time:
Jan/10/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 NAUSEA Oct/27/2020 13:00 NO
End Date Time:
Oct/28/2020 06:00
Repeating
Pages
3.ADVERSE EVE
NT 3 HEADACHE
Oct/27/2020 13:00 NO
End Date Time:
Oct/28/2020 06:00
Repeating
Pages
4.ADVERSE EVE
NT 4 BODY ACH
ES Oct/27/2020 13:00 NO
End Date Time:
Oct/28/2020 06:00
Repeating
Pages
5.ADVERSE EVE
NT 5 CHILLS Oct/27/2020 13:00 NO
End Date Time:
Oct/28/2020 06:00
Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806471
Page 61 of 198
***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: 11341378 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)[Bell's Palsy]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806472
Page 62 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806473
Page 63 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[NAUSEA]
4.Start Date Time: Oct/27/2020 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 06:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806474
Page 64 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806475
Page 65 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[HEADACHE]
4.Start Date Time: Oct/27/2020 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 06:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806476
Page 66 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806477
Page 67 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[BODY ACHES]
4.Start Date Time: Oct/27/2020 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 06:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806478
Page 68 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806479
Page 69 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CHILLS]
4.Start Date Time: Oct/27/2020 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 06:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806480
Page 70 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806481
Page 71 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806482
Page 72 of 198
***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: 11341378 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[ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806483
Page 73 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806484
Page 74 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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.Date: //
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806485
Page 75 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806486
Page 76 of 198
***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: 11341378 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?
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806487
Page 77 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806488
Page 78 of 198
***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: 11341378 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?
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806489
Page 79 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806490
Page 80 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806491
Page 81 of 198
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Nov/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806492
Page 82 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806493
Page 83 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806494
Page 84 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11341378 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?
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806495
Page 85 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806496
Page 86 of 198
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806497
Page 87 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806498
Page 88 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806499
Page 89 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806500
Page 90 of 198
***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: 11341378 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 [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806501
Page 91 of 198
***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: 11341378 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: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806502
Page 92 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806503
Page 93 of 198
***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
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806504
Page 94 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806505
Page 95 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806506
Page 96 of 198
***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: 11341378 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: [ ]
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806507
Page 97 of 198
***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: 11341378 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 Nov/24/2020
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806508
Page 98 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11341378 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
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806509
Page 99 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11341378 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 Mar-08-2021 16:30:03 (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.
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806510
Page 100 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-06-2020 17:58:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806511
Page 101 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-22-2021 09:24:18 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
FormJan-22-2021 09:23:53 (UTC-05:00) Eastern
Time (US & Canada)
FormJan-20-2021 16:38:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806512
Page 102 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
1Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806513
Page 103 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
2Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806514
Page 104 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
3Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806515
Page 105 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
4Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806516
Page 106 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
5Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
5Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806517
Page 107 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
6Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
6Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806518
Page 108 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
7Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
7Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806519
Page 109 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
8Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
8Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806520
Page 110 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Jan-22-2021 09:24:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
9Jan-22-2021 09:23:53 (UTC-05:00) Eastern Time
(US & Canada)
9Jan-20-2021 16:38:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3011\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-2021-5683-0806521
Page 111 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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 Mar-08-2021 16:30:03 (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-20-2021 18:16:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Feb-03-2021 13:08:23 (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-01-2021 14:56:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806522
Page 112 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jonathan
Wilson Approved Jan-22-2021 15:52:30 (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 Jan-22-2021 09:23:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Jan-21-2021 16:32:39 (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 Jan-18-2021 23:38:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Nov-30-2020 16:57:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806523
Page 113 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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.
N/A Nov-24-2020 17:31:31 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Nov-16-2020 13:06:13 (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 Nov-16-2020 11:07:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Nov-13-2020 12:48:31 (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.
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806524
Page 114 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
N/A Nov-13-2020 11:24:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Nov-10-2020 12:53:08 (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.
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806525
Page 115 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 17:53:51
(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-06-2020 17:53:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806526
Page 116 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-06-2020 17:54:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/6/2020Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806527
Page 117 of 198
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020 17:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11341378Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-06-2020 17:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1980Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-06-2020 17:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-06-2020 17:55:47
(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-06-2020 17:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806528
Page 118 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 17:56:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806529
Page 119 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 17:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 17:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020 17:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806530
Page 120 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Oct-06-2020 18:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:hepatitis C
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-06-2020 18:02:52
(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-06-2020 18:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hepatitis CInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-06-2020 18:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-06-2020 18:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3011\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-2021-5683-0806531
Page 121 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 18:17:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806532
Page 122 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
224.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
67.5Initial Entry
5. Unit:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.6Initial Entry
090177e196ae3011\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806533
Page 123 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.0
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-06-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806534
Page 124 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-06-2020 18:17:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-06-2020 18:17:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99723Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806535
Page 125 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 18:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-06-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 18:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNVMJRInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806536
Page 126 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 18:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNVMJRInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 18:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG019Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 18:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLG019Initial Entry
5.c
Date Location User Value Reason
Oct-06-2020 18:16:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9136Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 18:16:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9136Initial Entry
090177e196ae3011\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806537
Page 127 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 18:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 18:16:40
(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-06-2020 18:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 18:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-06-2020 18:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 10:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91DMChanged
Information
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806538
Page 128 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-06-2020 18:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91DNInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 10:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91DMChanged
Information
Oct-06-2020 18:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91DNInitial Entry
090177e196ae3011\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-2021-5683-0806539
Page 129 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 10:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 18:01:44
(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-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3011\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-2021-5683-0806540
Page 130 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7. Route:
Date Location User Value Reason
Oct-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-06-2020 18:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806541
Page 131 of 198
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-06-2020 18:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806542
Page 132 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-27-2020 16:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806543
Page 133 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2.a
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806544
Page 134 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.a Temperature Location:
Date Location User Value Reason
Oct-27-2020 16:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806545
Page 135 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 11:30:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 11:30:52
(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-27-2020 11:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 11:30:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 11:30:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 11:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91JRInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806546
Page 136 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 11:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91JRInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806547
Page 137 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 09:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020 16:50:49
(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-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3011\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-2021-5683-0806548
Page 138 of 198
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7. Route:
Date Location User Value Reason
Oct-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-27-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806549
Page 139 of 198
***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: 11341378 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-24-2020 19:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806550
Page 140 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 17:31:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 17:31:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 17:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-24-2020 17:31:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-24-2020 17:31:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020 17:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMS0GInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806551
Page 141 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Nov-24-2020 17:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMS0GInitial Entry
5.b
Date Location User Value Reason
Nov-24-2020 17:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMS0WInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020 17:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMS0WInitial Entry
5.c
Date Location User Value Reason
Nov-24-2020 17:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCWN7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-24-2020 17:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCWN7Initial Entry
090177e196ae3011\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),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806552
Page 142 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11341378 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-23-2021 02:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Closed Response satisfies
query
Feb-22-2021 08:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered Subject is scheduled
to come in for this
visit today at
11:00am
Feb-22-2021 06:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Opened PDQ: Convalescent
visit is missing and
35 days (38) have
passed since
COVID Illness
Visit. If visit
occurred record data
as a matching
CONVA visit; if
visit did not occur
attempt to schedule
visit even if OOW
and obtain the
CONVA sample
else clarify.
Feb-02-2021 15:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Feb-02-2021 08:54:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered The subject did not
call Marken for a
pickup therefore we
did not receive a
self nasal swab.
Feb-02-2021 05:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Opened PDQ : Details of
Sample ID
(barcode) and
collection date for
either Nasal Swab
Self or Nasal Swab
090177e196ae3011\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), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806553
Page 143 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
expected to be
completed. Please
check and update
else clarify.
Feb-01-2021 14:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Jan-25-2021 05:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Jan-22-2021 09:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered updated
Jan-21-2021 07:29:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Jan-21-2021 02:32:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened ‘Microbiology
Specimen
form':Form level
comment is
currently blank.
Remove all entered
data using the eraser
icon. Once all
entered data has
been removed, an
option to tick Not
Applicable/Not
done becomes
available. Please
update.
Jan-20-2021 16:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered updated
090177e196ae3011\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), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806554
Page 144 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-20-2021 16:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Updated
Jan-20-2021 10:27:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened DM: Kindly review
and complete
‘Health Care
Utilization,
Microbiology
Specimen form' at
this visit. Thank
you.
Jan-20-2021 01:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Date of Visit is
completed but Nasal
Swab (SWAB PFE)
CRF is not initiated.
Please review and
update the data as
appropriate. Thanks
Jan-18-2021 23:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-18-2021 23:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-18-2021 23:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
090177e196ae3011\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-2021-5683-0806555
Page 145 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-18-2021 23:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-18-2021 23:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806556
Page 146 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-04-2021 09:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resol
ved:
Jan/21/2021Transcription Error
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806557
Page 147 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
4.a Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806558
Page 148 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.c Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
NInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806559
Page 149 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sympto
m Presen
t:YES
4.e Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae3011\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806560
Page 150 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
090177e196ae3011\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-2021-5683-0806561
Page 151 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.h Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-18-2021 23:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-18-2021 23:41:24
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Symptoms - Other: nauseaInitial Entry
090177e196ae3011\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), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806562
Page 152 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-18-2021 23:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
nauseaInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806563
Page 153 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806564
Page 154 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
4. Assay Code and Description:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806565
Page 155 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7. Test Result:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-22-2021 09:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 16:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806566
Page 156 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021 23:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021 23:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-02-2021 07:54:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 14:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-01-2021 14:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No
and 'If no sample
was collected or
sample was not
collected according
to protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Feb-01-2021 14:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Feb-01-2021 14:56:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOsubject did not call
Marken for the
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806567
Page 157 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) pickup.
Feb-01-2021 14:23:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Form has
been unfrozen.
Feb-01-2021 09:48:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Please unfreeze
this field
Feb-01-2021 05:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please enter reason
at field 4 of this
CRF.
Jan-29-2021 10:41:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject did not call
Marken to pickup
the self nasal swab
therefore we have
no barcode to enter.
Jan-29-2021 07:28:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-22-2021 14:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate DM: re-issue query
if barcode not
entered at a later
date
Jan-22-2021 09:22:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered CRC will confirm
if the subject called
for a pickup for the
self nasal swab
Jan-20-2021 07:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-18-2021 23:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
090177e196ae3011\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),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806568
Page 158 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
review and correct
as appropriate.
Jan-18-2021 23:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/15/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-01-2021 14:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject did not call Marken for a p
ickup.Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806569
Page 159 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 16:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 16:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 16:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-20-2021 16:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT DID THE SELF SWABInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806570
Page 160 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:EMERGENC
Y ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3011\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-2021-5683-0806571
Page 161 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3011\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806572
Page 162 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3011\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-2021-5683-0806573
Page 163 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-20-2021 16:39:25
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806574
Page 164 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806575
Page 165 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/15/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-18-2021 23:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-18-2021 23:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-18-2021 23:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806576
Page 166 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - 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: 11341378 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-22-2021 17:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-22-2021 17:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806577
Page 167 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-22-2021 17:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021 17:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 17:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-22-2021 17:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-22-2021 17:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021 17:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BV094HInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806578
Page 168 of 198
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/22/2021Form: 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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 17:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BV094HInitial Entry
5.b
Date Location User Value Reason
Feb-22-2021 17:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS1HHGInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-22-2021 17:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS1HHGInitial Entry
5.c
Date Location User Value Reason
Feb-22-2021 17:18:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS1HJRInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-22-2021 17:18:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS1HJRInitial Entry
090177e196ae3011\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),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806579
Page 169 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806580
Page 170 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806581
Page 171 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806582
Page 172 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806583
Page 173 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806584
Page 174 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 11:24:13
(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-04-2020 16:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-04-2020 15:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered I confirmed that
Lyme Titres were
not sent. The patient
was also only on
those medications
for 7 days (1 week
duration). I also
confirmed that this
AE is ongoing. The
patient only has
25% of their facial
movement back.
Dec-04-2020 12:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened clinical: Thank you,
how many days for
prednisone and
valtrex? Were Lyme
titres sent?
Dec-04-2020 11:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Prednisone 20 mg
once daily Valtrex
1,000 mg once daily
090177e196ae3011\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-2021-5683-0806585
Page 175 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Dec-04-2020 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened clin: Thank you.
Can you pls provide
the dose and
duration for
prednisone and
Valtrex. Were Lyme
titres (antibodies)
sent?
Dec-04-2020 10:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Subject did not
report prior history
of any blistering
rash. Subject took
Prednisone, refresh
eye drops and
valtrex for
treatment. Per the
source this is still
ongoing.
Dec-04-2020 09:33:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened clin: pls confirm no
prior hx of any
blistering rash,
advise which
medications used
for treatment and if
subject's symptoms
have resolved or if
subject has any
sequelae. Were
Lyme titres sent?
Thank you
Dec-04-2020 09:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed reissued.
Dec-04-2020 08:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened clin: pls confirm no
prior hx of Bell's
palsy, advise which
if any medications
used for treatment
and advise if
subject's symptoms
have resolved yet.
Thank you.
Nov-19-2020 13:37:07 ACV0PFEINFP6000 Query 2: Closed Response satisfies
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806586
Page 176 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)query
Nov-19-2020 11:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered This was reported
as related by Dr.
Wilson because
other vaccines are
know to cause
Bell's Palsy and the
subject reported
having no recent
infections of any
kind. No history of
Bell's Palsy or
Herpes infections
were reported by
the subject either.
Nov-19-2020 11:06:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened clinical: pls advise
as to basis for
determining AE
related and advise if
subject has prior hx
of Bell's palsy or
herpes infections.
Thanks
Nov-16-2020 15:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-16-2020 10:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this has been
uplaoded into
florence. thank you
Nov-14-2020 14:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Please upload AE
source to Florence
in order to verify
data.
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bell's PalsyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 11:24:13 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806587
Page 177 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)Nov/4/2020 UNK:UNK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 13:08:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-23-2021 16:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-23-2021 16:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UNKTranscription Error
Feb-22-2021 12:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
BELL'S PALSY ( 04
Nov 20) is still
reported as
ONGOING. Please
confirm or enter
END DATE if
known.
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae3011\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806588
Page 178 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3011\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806589
Page 179 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Feb-23-2021 16:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-23-2021 16:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDTranscription Error
Feb-23-2021 16:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Bell's Palsy :
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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-2021-5683-0806590
Page 180 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NAUSEAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/28/2020 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3011\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-2021-5683-0806591
Page 181 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806592
Page 182 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 11:07:58
(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
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 11:07:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806593
Page 183 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/28/2020 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3011\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-2021-5683-0806594
Page 184 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806595
Page 185 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 11:09:21
(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
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 11:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806596
Page 186 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BODY ACHESInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/28/2020 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3011\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-2021-5683-0806597
Page 187 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806598
Page 188 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 11:10:22
(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
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 11:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806599
Page 189 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/28/2020 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3011\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-2021-5683-0806600
Page 190 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\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),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806601
Page 191 of 198
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 11:11:08
(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
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 11:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806602
Page 192 of 198
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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
Nov-24-2020 19:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-24-2020 19:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-24-2020 19:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806603
Page 193 of 198
***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: 11341378 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-23-2021 22:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Transcription Error
Feb-20-2021 18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806604
Page 194 of 198
***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
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 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-23-2021 22:07:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Changed
Information
Feb-20-2021 18:16:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retur
n for Vaccination 3 OR otherwise
not eligibleInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806605
Page 195 of 198
***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: 11341378 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-20-2021 18:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-24-2021
10:38:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Feb-23-2021
22:12:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per query
Feb-22-2021
14:39:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7350222;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-20-2021
18:16:30
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3011\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)
(b) (4)
FDA-CBER-2021-5683-0806606
Page 196 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806607
Page 197 of 198
***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: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-24-2020 19:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-06-2020 18:17:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-06-2020 17:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-24-2020 19:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/24/2020Initial Entry
Oct-06-2020 18:17:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Oct-06-2020 17:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806608
Page 198 of 198
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 10:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3011\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806609