Document text
Page 1 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805409
Page 2 of 214
***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: 11341085 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
Aug/17/2020
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805410
Page 3 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11341085]
2.Birth Date: /1962
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805411
Page 4 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805412
Page 5 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805413
Page 6 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805414
Page 7 of 214
***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: 11341085 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:[ALLERGY TO CODEINE]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO NAPROXEN]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO SHELL FISH]
Start Date: UNK/UNK/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO SULFER]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805415
Page 8 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2010
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ATRIAL FIBRILLATION]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805416
Page 9 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[EDEMA (UPPER AND LOWER EXTREMITY)]
Start Date: UNK/UNK/2010
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS (UPPER AND LOWER EXTREMITY)]
Start Date: UNK/UNK/1980
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST MENOPAUSAL]
Start Date: UNK/UNK/2011
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[(RIGHT) HIP REPLACEMENT]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805417
Page 10 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[(LEFT) PARTIAL HIP REPLACEMENT]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[(RIGHT) SHOULDER SURGERY]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ABLAtion]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805418
Page 11 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [231.0]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [40.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805419
Page 12 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805420
Page 13 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [229178]
3.Randomization Group: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805421
Page 14 of 214
***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: 11341085 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:
Aug/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPHCHL]
5.bSample ID [BPHCHM]
5.cSample ID [BP1L11]
5.dSample ID [BP1L12]
5.eSample ID [BP1L13]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805422
Page 15 of 214
***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: 11341085 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:
Aug/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1KTC]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805423
Page 16 of 214
***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: 11341085 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: Aug/17/2020 10:26
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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805424
Page 17 of 214
***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: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805425
Page 18 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805426
Page 19 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: EAR
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805427
Page 20 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805428
Page 21 of 214
***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: 11341085 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:
Sep/8/2020
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 [BP9LKM]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805429
Page 22 of 214
***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: 11341085 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: Sep/8/2020 08:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805430
Page 23 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805431
Page 24 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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/12/2020
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 [BLFZHP]
5.bSample ID [BLFZGM]
5.cSample ID [BM91KH]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805432
Page 25 of 214
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805433
Page 26 of 214
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11341085 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:
Mar/8/2021
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 [BR1BSC]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805434
Page 27 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805435
Page 28 of 214
***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: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805436
Page 29 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805437
Page 30 of 214
***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: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805438
Page 31 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805439
Page 32 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805440
Page 33 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805441
Page 34 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805442
Page 35 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805443
Page 36 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805444
Page 37 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805445
Page 38 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805446
Page 39 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805447
Page 40 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805448
Page 41 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805449
Page 42 of 214
***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: 11341085 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: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805450
Page 43 of 214
***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: 11341085 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:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805451
Page 44 of 214
***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: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805452
Page 45 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 COMPRESSED CERVI
CAL DISC Dec/15/2020 UN
K:UNK NO
End Date Time:
Dec/31/2020 UNK:UN
K
Repeating
Pages
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805453
Page 46 of 214
***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: 11341085 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)[COMPRESSED CERVICAL DISC]
4.Start Date Time: Dec/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/31/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805454
Page 47 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[IDIOPATHIC]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[2021109738]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805455
Page 48 of 214
***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: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805456
Page 49 of 214
***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: 11341085 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[ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805457
Page 50 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.1 VACCINATIONS NO shingles vaccin
e Feb/UNK/
2021 Repeating
Pages
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805458
Page 51 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[shingles vaccine]
5.Date: Feb/UNK/2021
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805459
Page 52 of 214
***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: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805460
Page 53 of 214
***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: 11341085 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?
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805461
Page 54 of 214
***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: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805462
Page 55 of 214
***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: 11341085 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?
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805463
Page 56 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805464
Page 57 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805465
Page 58 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805466
Page 59 of 214
***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: 11341085 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:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805467
Page 60 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805468
Page 61 of 214
***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: 11341085 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?
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805469
Page 62 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805470
Page 63 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805471
Page 64 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805472
Page 65 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805473
Page 66 of 214
***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: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805474
Page 67 of 214
***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: 11341085 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 [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805475
Page 68 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/2/2021
2.Erroneous Visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805476
Page 69 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
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 1/2Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805477
Page 70 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805478
Page 71 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805479
Page 72 of 214
***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: 11341085 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: [ ]
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805480
Page 73 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit ERRONEOUS VISIT Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805481
Page 74 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Applicable Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805482
Page 75 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805483
Page 76 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805484
Page 77 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805485
Page 78 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805486
Page 79 of 214
***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: 11341085 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 Oct/12/2020
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805487
Page 80 of 214
***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: 11341085 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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805488
Page 81 of 214
***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: 11341085 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-11-2021 11:25:34 (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.
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805489
Page 82 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-17-2020 13:07:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805490
Page 83 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Aug-17-2020 13:42:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805491
Page 84 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805492
Page 85 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Sep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805493
Page 86 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Sep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805494
Page 87 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Sep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805495
Page 88 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Sep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805496
Page 89 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Sep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805497
Page 90 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805498
Page 91 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805499
Page 92 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-08-2020 21:01:37 (UTC-05:00) Eastern
Time (US & Canada)ND
Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805500
Page 93 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - Comments
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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-28-2021 18:48:05 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
FormFeb-25-2021 09:01:47 (UTC-05:00) Eastern
Time (US & Canada)
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Time (US & Canada)Not Applicable
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
1Feb-25-2021 09:01:47 (UTC-05:00) Eastern
Time (US & Canada)
1Feb-01-2021 09:36:56 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
1Feb-01-2021 09:26:46 (UTC-05:00) Eastern
Time (US & Canada)
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(b) (4), (b) (6)
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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2Jan-21-2021 08:23:56 (UTC-05:00) Eastern
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Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
1Jan-20-2021 16:09:53 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
FormJan-21-2021 10:01:57 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-21-2021 10:01:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Jan-20-2021 16:10:16 (UTC-05:00) Eastern Time
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(b) (4), (b) (6)
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Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-21-2021 10:01:57 (UTC-05:00) Eastern Time
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Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-21-2021 10:01:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Jan-20-2021 16:10:43 (UTC-05:00) Eastern Time
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(b) (4), (b) (6)
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Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Jan-21-2021 10:01:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Jan-20-2021 16:10:35 (UTC-05:00) Eastern Time
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Jan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Jan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aJan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aJan-18-2021 23:20:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
6.aJan-18-2021 23:20:47 (UTC-05:00) Eastern
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090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
FormJan-20-2021 16:12:13 (UTC-05:00) Eastern
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Jan-20-2021 16:11:06 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
2Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
3Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
4Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Jan-20-2021 16:11:24 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
6Jan-20-2021 16:11:44 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
10Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
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Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
11Jan-20-2021 16:12:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
11Jan-20-2021 16:12:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805534
Page 127 of 214
***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: 11341085 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-11-2021 11:25:34 (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 Mar-09-2021 17:01:20 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Mar-09-2021 10:18:58 (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 Mar-08-2021 17:40:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805535
Page 128 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jonathan
Wilson Approved Mar-04-2021 16:49:22 (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 Mar-02-2021 12:50:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Feb-26-2021 13:56:09 (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-25-2021 08:59:31 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Feb-05-2021 14:11:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805536
Page 129 of 214
***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: 11341085 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 Feb-05-2021 09:15:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Feb-03-2021 09:33:46 (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-28-2021 18:47:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Jan-21-2021 15:55:55 (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.
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0805537
Page 130 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
N/A Jan-18-2021 23:17:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan
Wilson Approved Oct-20-2020 11:32:36 (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.
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0805538
Page 131 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
Aug-17-2020 13:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020 13:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805539
Page 132 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 13:06:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/17/2020Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805540
Page 133 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 13:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11341085Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 13:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1962Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 13:06:51
(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
Aug-17-2020 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805541
Page 134 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 13:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805542
Page 135 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
Aug-17-2020 13:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 13:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 13:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805543
Page 136 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020 13:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:ALLERGY TO C
ODEINE
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALLERGY TO CODEINEInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 13:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020 13:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805544
Page 137 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-17-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:ALLERGY TO N
APROXEN
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALLERGY TO NAPROXENInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-17-2020 13:27:39
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Line/MH Nu 3Transcription Error
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805545
Page 138 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) mber:
Medical Histo
ry Term:ALLERGY TO S
HELL FISH
Start Date: UNK/UNK/2014
Ongoing: YES
Aug-17-2020 13:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:ALLERGY TO S
HELLFISH
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0805546
Page 139 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALLERGY TO SHELL FISHTranscription Error
Aug-17-2020 13:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALLERGY TO SHELLFISHInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-17-2020 13:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-17-2020 13:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-17-2020 13:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:ALLERGY TO S
ULFER
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805547
Page 140 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALLERGY TO SULFERInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-17-2020 13:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-17-2020 13:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-17-2020 13:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:HYPERCHOLEST
EROLEMIA
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805548
Page 141 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-17-2020 13:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-17-2020 13:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-17-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:HYPERTENS
ION
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805549
Page 142 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSIONInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-17-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-17-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-17-2020 13:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:GASTROESOPHA
GEAL REFLUX DI
SEASE
Start Date
:UNK/UNK/2010
Ongoing: YESTranscription Error
Aug-17-2020 13:29:14
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH 7Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805550
Page 143 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) Number:
Medical Hi
story Term
:GASTROESOPHA
GEAL REFUL DIS
EASE
Start Date: UNK/UNK/2010
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:29:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GASTROESOPHAGEAL REFL
UX DISEASETranscription Error
Aug-17-2020 13:29:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GASTROESOPHAGEAL REFU
L DISEASEInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-17-2020 13:29:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-17-2020 13:29:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-17-2020 13:29:44 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805551
Page 144 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Number: 8
Medical History T
erm:DEPRESSIO
N
Start Date: UNK/UNK/2
010
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEPRESSIONInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-17-2020 13:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-17-2020 13:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-17-2020 13:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805552
Page 145 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical Histor
y Term:ATRIAL FIBRIL
LATION
Start Date: UNK/UNK/2017
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ATRIAL FIBRILLATIONInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-17-2020 13:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-17-2020 13:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-17-2020 13:31:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical Hi
story Term
:EDEMA (UPPER AN
D LOWER EXTREM
ITY)Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805553
Page 146 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805554
Page 147 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:31:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:31:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EDEMA (UPPER AND LOWER
EXTREMITY)Initial Entry
1.j Start Date:
Date Location User Value Reason
Aug-17-2020 13:31:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-17-2020 13:31:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-19-2020 15:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:11
Medical
History T
erm:OSTEOARTHRITIS (
UPPER AND LOWE
R EXTREMITY)
Start Dat
e:UNK/UNK/1980
Ongoing: YESTranscription Error
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805555
Page 148 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-17-2020 13:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:ARTHRITIS (UPPER
AND LOWER EXTR
EMITY)
Start Dat
e:UNK/UNK/1980
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805556
Page 149 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 15:21:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-19-2020 15:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-19-2020 15:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OSTEOARTHRITIS (UPPER AN
D LOWER EXTREMITY)Transcription Error
Aug-19-2020 14:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN -
Condition
ARTHRITIS is
reported. Please
specify type of
Arthritis (Osteo or
Rheumatoid).
Aug-17-2020 13:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ARTHRITIS (UPPER AND LOW
ER EXTREMITY)Initial Entry
1.k Start Date:
Date Location User Value Reason
Aug-17-2020 13:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-17-2020 13:32:33
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805557
Page 150 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
1.l
Date Location User Value Reason
Aug-17-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:POST MENOPA
USAL
Start Date: UNK/UNK/201
1
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POST MENOPAUSALInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-17-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-17-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805558
Page 151 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-17-2020 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:(RIGHT) HIP REP
LACEMENT
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/199
8Transcription Error
Aug-17-2020 13:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:(RIGHT) HIP RE
PLACEMENT
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805559
Page 152 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.m Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
(RIGHT) HIP REPLACEMENTInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-17-2020 13:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-17-2020 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Transcription Error
Aug-17-2020 13:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-17-2020 13:35:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:14
Medical Hi
story Term:(LEFT) PARTIAL HI
P REPLACEMENT
Start Date: UNK/UNK/2008Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805560
Page 153 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/2008
1.n Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:35:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:35:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
(LEFT) PARTIAL HIP REPLACE
MENTInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-17-2020 13:35:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-17-2020 13:35:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.o
Date Location User Value Reason
Aug-17-2020 13:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:15
Medical Hist
ory Term:(RIGHT) SHOULD
ER SURGERYInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805561
Page 154 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.o Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
(RIGHT) SHOULDER SURGERYInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-17-2020 13:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-17-2020 13:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.p
Date Location User Value Reason
Aug-17-2020 15:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:16Transcription Error
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805562
Page 155 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical Histor
y Term:ABLAtion
Start Date: UNK/UNK/20
18
Ongoing: NO
End Date:
UNK/UNK
/2018
Aug-17-2020 13:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16
Medical Histor
y Term:ABLASION
Start Date: UNK/UNK/20
18
Ongoing: NO
End Date:
UNK/UNK
/2018Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805563
Page 156 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.p Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020
14:55:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Close
dResponse
satisfies query
Aug-19-2020
14:12:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answ
eredSubject had
ablation due to
Atrial
Fibrillation.
Aug-19-2020
01:40:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Katherine Liau Query 2: Opene
dPlease provide
body
site/location of
ablation in the
medical history
term.
Aug-17-2020
18:01:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Close
dDiscrepancy
has been
closed.
Aug-17-2020
15:14:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Aug-17-2020
15:14:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ABLAtionTranscription
Error
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0805564
Page 157 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-17-2020
15:08:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opene
dPlease correct
spelling of
ABLASION to
ABLATION.
Thank you.
Aug-17-2020
13:37:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ABLASIONInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-17-2020 13:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-17-2020 13:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.q
Date Location User Value Reason
Aug-17-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:17
Medical History
Term:HYSTERECTO
MY
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0805565
Page 158 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.q Line/MH Number:
Date Location User Value Reason
Aug-17-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYSTERECTOMYInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-17-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-17-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805566
Page 159 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
231.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
40.9Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805567
Page 160 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805568
Page 161 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-17-2020 13:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020 13:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020 13:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020 13:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-17-2020 13:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805569
Page 162 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 13:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 13:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
229178Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805570
Page 163 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 13:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 13:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 13:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 13:15:26
(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.
Aug-17-2020 13:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 13:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHCHLInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805571
Page 164 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 13:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHCHLInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 13:15:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHCHMInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 13:15:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHCHMInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 18:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1L11Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 18:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1L11Initial Entry
5.d
Date Location User Value Reason
Aug-17-2020 18:14:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1L12Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805572
Page 165 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 18:14:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1L12Initial Entry
5.e
Date Location User Value Reason
Aug-17-2020 18:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1L13Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 18:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1L13Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805573
Page 166 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 13:14:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 13:14:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 13:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 13:14:59
(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.
Aug-17-2020 13:14:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 13:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1KTCInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805574
Page 167 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 13:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1KTCInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805575
Page 168 of 214
***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: 11341085 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
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020 10:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805576
Page 169 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7. Route:
Date Location User Value Reason
Aug-17-2020 13:41:36
(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
Aug-17-2020 13:41:36
(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
Aug-17-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805577
Page 170 of 214
***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: 11341085 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
Aug-17-2020 17:41:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTTranscription Error
Aug-17-2020 13:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805578
Page 171 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 21:00:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805579
Page 172 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.9
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805580
Page 173 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-08-2020 21:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805581
Page 174 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805582
Page 175 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) Sponsor-Defined Identi
fier:Not Do
ne
Test:: Not Do
ne
Result:: Not Do
ne
Not Done:: Not Do
ne
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-08-2020 21:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805583
Page 176 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 19:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 19:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 19:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 19:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 19:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 19:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LKMInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805584
Page 177 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 19:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9LKMInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805585
Page 178 of 214
***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: 11341085 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
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 08:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805586
Page 179 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7. Route:
Date Location User Value Reason
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 21:06:15
(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
Sep-08-2020 21:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805587
Page 180 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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-12-2020 20:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805588
Page 181 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 18:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 18:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 18:07:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 18:07:37
(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-12-2020 18:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 18:07:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFZHPInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805589
Page 182 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 18:07:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFZHPInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020 18:08:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFZGMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 18:08:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFZGMInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 18:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91KHInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 18:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91KHInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805590
Page 183 of 214
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 07:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805591
Page 184 of 214
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 17:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 17:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 17:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 17:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 17:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021 17:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR1BSCInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805592
Page 185 of 214
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 17:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR1BSCInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0805593
Page 186 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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-12-2020 20:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 20:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 20:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805594
Page 187 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805595
Page 188 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-02-2021 16:32:54
(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
Feb-25-2021 10:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thanks for the
response
Feb-19-2021 10:34:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered We do not have any
updates we are still
waiting for medical
records
Feb-19-2021 10:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Could you provide
an update? thanks
Feb-12-2021 10:57:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Medical records
have been
requested- once we
have this we will
update.
Feb-10-2021 16:33:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened MEDICAL
MONITOR_ Per
report, subject was
hospitalized 7 days
and underwent
surgery. Pls provide
discharge summary
with imaging test,
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0805596
Page 189 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
procedure
performed, and
management while
in the hospital.
Thanks.
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPRESSED CERVICAL DIS
CInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/31/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-05-2021 09:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805597
Page 190 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
COMPRESSED
CERVICAL DISC:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
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.
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805598
Page 191 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Feb-02-2021 16:32:54
(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
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
IDIOPATHICInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-02-2021 16:32:54
(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
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805599
Page 192 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-02-2021 16:32:54
(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
Feb-02-2021 16:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-05-2021 09:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021109738Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805600
Page 193 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805601
Page 194 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
shingles vaccineInitial Entry
5. Date:
Date Location User Value Reason
Mar-09-2021 17:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2021Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805602
Page 195 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 02:33:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Mar-03-2021 08:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered updated
Mar-03-2021 08:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Mar-02-2021 23:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM: If visit is
erroneous delete
data entered on
REVAX CONF
form and mark
form level
comment as Not
Applicable or else
clarify. Thank you.
Mar-02-2021 12:50:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Mar-02-2021 12:50:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Mar-02-2021 12:50:15 ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),(b)(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805603
Page 196 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)Jan/2/2021
Mar-02-2021 12:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM: Form is
unfrozen. Please
review and update
as appropriate.
Mar-02-2021 09:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Confirmed that
subject had a revax
call on
02FEB2021- please
unfreeze this so that
it can be updated.
Thank you.
Mar-02-2021 08:33:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Date of Visit
is reported as
Erroneous Visit,
however ‘Further
Vaccination’ is
reported for this
visit, kindly review
this form if require,
else mark as Not
applicable by
selecting form level
comment. Thank
you.
Feb-01-2021 15:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-01-2021 09:37:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered updated
Feb-01-2021 04:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Item level
comment provided
instead of form
level comment on
REVAX CONF
form. Kindly clear
the item comment
and then add form
level comment by
selecting Not Done
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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)
FDA-CBER-2021-5683-0805604
Page 197 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
or Not Applicable
as radio button at
form level on
REVAX CONF
form or else clarify.
Jan-29-2021 13:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-29-2021 08:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered visit is erroneous
Jan-28-2021 23:43:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Erroneous
visit is marked.
However, data is
present on REVAX
CONF form. Please
consider to erase
the data and add
form level
comment by
selecting Not done
or Not applicable
option on REVAX
CONF form of this
visit or else clarify.
Jan-28-2021 18:48:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered visit mark aw
erroneous
Jan-28-2021 18:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805605
Page 198 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-28-2021 16:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per our discussion,
the visit was
erroneous. Please
mark as such.
Jan-18-2021 23:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-03-2021 08:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-28-2021 18:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805606
Page 199 of 214
***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: 11341085 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-25-2021 09:02:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
Feb-25-2021 09:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Feb-01-2021 09:36:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-01-2021 09:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-29-2021 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-29-2021 08:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national r
ecommendations and confir
med to have received only
placebo at Vaccination 1/2Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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)
FDA-CBER-2021-5683-0805607
Page 200 of 214
***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: 11341085 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-25-2021 08:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Transcription Error
Jan-18-2021 23:17:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-26-2021
13:05:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Feb-25-2021
09:03:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dThe DOV in the revax
section is indeed
frozen- please
UNFREEZE this so I
can update the date.
Feb-25-2021
05:48:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: REVAX CONF
form is not frozen,
kindly review and
update.
Feb-24-2021
04:32:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Candi
dateDM: REVAX CONF
form is not frozen,
kindly review and
update.
Feb-23-2021
13:33:29ACV0PFEINFP6000 Query
1: AnPlease unfreeze the
revax confirmation
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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)
FDA-CBER-2021-5683-0805608
Page 201 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time
(US &
Canada)swere
dsection so I can update
this.
Feb-22-2021
13:15:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7350033;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.
Jan-18-2021
23:17:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0805609
Page 202 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021 23:29:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-21-2021 10:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered updated
Jan-21-2021 02:57:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-21-2021 00:34:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Erroneous
visit is marked.
However, form
level comment is
not present on
DISP RESCR form
of this visit. Please
review and add
form level
comment by
selecting Not Done
or Not Applicable
option on DISP
RESCR form by
erasing item
comments else,
clarify.
Jan-20-2021 16:09:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Visit 101VAX3 did
not occur yet- this
was entered in
error by another
user.
Jan-20-2021 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805610
Page 203 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Jan-20-2021 04:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to update
missing SWAB
PFE and SAMP
TRK forms or else
clarify. Thank you.
Jan-18-2021 23:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-20-2021 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805611
Page 204 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-20-2021 16:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:19:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Jan/12/2021Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805612
Page 205 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
Jan-20-2021 16:10:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:20:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-21-2021 10:01:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:20:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-20-2021 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:10:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:20:35
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805613
Page 206 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
4. Specify Status:
Date Location User Value Reason
Jan-20-2021 16:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0805614
Page 207 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805615
Page 208 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-18-2021 23:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805616
Page 209 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 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
Jan-20-2021 16:11:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:10:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805617
Page 210 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4. Dose Date Time:
Date Location User Value Reason
Jan-21-2021 16:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Updated to Not
Applicable for
entire visit
Jan-20-2021 16:11:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-19-2021 19:13:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
VAX 3 was
administered on 12
Jan 21. However,
the SAMP TRK and
SWAB PFE pages
remain BLANK.
Please review and
update.
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021 14:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0805618
Page 211 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
6. Body Side:
Date Location User Value Reason
Jan-20-2021 16:11:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805619
Page 212 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-20-2021 16:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-20-2021 16:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 16:11:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-18-2021 23:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0805620
Page 213 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020 20:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020 13:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-17-2020 13:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-12-2020 20:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-17-2020 13:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
Aug-17-2020 13:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae300c\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0805621
Page 214 of 214
***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: 11341085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020 11:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEI
…[truncated]