125742 S1 M5 CRF c4591001 1122 11221026

Document text

Page 1 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930299
Page 2 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930300
Page 3 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11221026]
2.Birth Date: /1995
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930301
Page 4 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930302
Page 5 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930303
Page 6 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930304
Page 7 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Medical History Details
1.Line/MH Number: Not Done
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Done
[ ]
Start Date: Not Done
//
Ongoing: Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930305
Page 8 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
2.Weight: Not Done
[ ]Comments
3.Unit: Not Done Comments
4.Height: Not Done
[ ]Comments
5.Unit: Not Done Comments
6.Body Mass Index: Not Done
[ ]Comments
Vital Signs Details
7.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930306
Page 9 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [87404]
3.Randomization Group: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930307
Page 10 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Sep/11/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHC0WD]
5.bSample ID [BHC0WF]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930308
Page 11 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930309
Page 12 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930310
Page 13 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNot Done Comments
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930311
Page 14 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit // Comments
2.Erroneous Visit ERRONEOUS VISIT Comments
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930312
Page 15 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930313
Page 16 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930314
Page 17 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930315
Page 18 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930316
Page 19 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930317
Page 20 of 152
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930318
Page 21 of 152
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930319
Page 22 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930320
Page 23 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930321
Page 24 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930322
Page 25 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930323
Page 26 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930324
Page 27 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930325
Page 28 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930326
Page 29 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930327
Page 30 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930328
Page 31 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930329
Page 32 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930330
Page 33 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930331
Page 34 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930332
Page 35 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930333
Page 36 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  vomiting  Sep/11/2020 UNK:UN
K NO
End Date Time:
Sep/11/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVEN
T 2  pre-syncope  Sep/11/2020 UNK:UN
K NO
End Date Time:
Sep/11/2020 UNK:UNK
 Repeating
Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930334
Page 37 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[vomiting]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[blood draw]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930335
Page 38 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930336
Page 39 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pre-syncope]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[blood draw]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930337
Page 40 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930338
Page 41 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930339
Page 42 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930340
Page 43 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930341
Page 44 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930342
Page 45 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930343
Page 46 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930344
Page 47 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930345
Page 48 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930346
Page 49 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930347
Page 50 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930348
Page 51 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930349
Page 52 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930350
Page 53 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930351
Page 54 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930352
Page 55 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930353
Page 56 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930354
Page 57 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930355
Page 58 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930356
Page 59 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930357
Page 60 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930358
Page 61 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930359
Page 62 of 152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930360
Page 63 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930361
Page 64 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930362
Page 65 of 152
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/11/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930363
Page 66 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930364
Page 67 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930365
Page 68 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/11/2020
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930366
Page 69 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930367
Page 70 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930368
Page 71 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-16-2020 15:41:25 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormNov-16-2020 15:26:49 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-25-2020 10:03:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930369
Page 72 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:11:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930370
Page 73 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930371
Page 74 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930372
Page 75 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930373
Page 76 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930374
Page 77 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930375
Page 78 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930376
Page 79 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Nov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930377
Page 80 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7.aNov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930378
Page 81 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7.aNov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930379
Page 82 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7.aNov-09-2020 15:11:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930380
Page 83 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)
FormNov-09-2020 15:11:58 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930381
Page 84 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)
1Nov-09-2020 15:11:58 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930382
Page 85 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Feb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-09-2020 15:11:58 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930383
Page 86 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-09-2020 15:11:58 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930384
Page 87 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)
4Nov-09-2020 15:11:58 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930385
Page 88 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930386
Page 89 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-09-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930387
Page 90 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-09-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930388
Page 91 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-09-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930389
Page 92 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-09-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930390
Page 93 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930391
Page 94 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930392
Page 95 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930393
Page 96 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930394
Page 97 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930395
Page 98 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930396
Page 99 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930397
Page 100 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930398
Page 101 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930399
Page 102 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930400
Page 103 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
10Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930401
Page 104 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Nov-09-2020 15:12:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930402
Page 105 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:12:52 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930403
Page 106 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-09-2020 15:12:52 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930404
Page 107 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-09-2020 15:11:03 (UTC-05:00) Eastern Time
(US & Canada)
FormNov-09-2020 15:10:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930405
Page 108 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-09-2020 15:11:03 (UTC-05:00) Eastern Time
(US & Canada)
1Nov-09-2020 15:10:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930406
Page 109 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-09-2020 15:11:03 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-09-2020 15:10:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930407
Page 110 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-11-2021 10:36:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Margaret Tiktin  Approved Nov-16-2020 16:21:21 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MargaretTiktin, 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.
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930408
Page 111 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020 15:56:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-11-2020 15:56:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930409
Page 112 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-26-2020 02:18:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Subject is Screen
Failure
Sep-25-2020 10:04:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Sep-25-2020 06:59:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Subject consent
was obtained on
11SEP2020 however
rest of the visit details
on V1D1VX1L,
SUBJSTAT are
missing. Kindly
consider updating
missing forms or else
clarify. Thank you.
Sep-11-2020 15:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/11/2020Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930410
Page 113 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 15:56:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11221026Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020 15:56:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1995Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020 15:57:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-11-2020 15:57:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020 15:57:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930411
Page 114 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 11:44:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-05-2020 09:03:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Specimen
Destruction request
form was completed
and submitted.
Oct-02-2020 08:51:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Barcode BJL3ZL has
been received by the
lab for Visit 1. Please
review and update or
submit SCF.
Sep-25-2020 10:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930412
Page 115 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-25-2020 10:04:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 10:04:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-09-2020
15:04:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Cl
osedClose Auto Query
Nov-09-2020
15:04:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Op
enedResponse to
"Status" is
COMPLETED but
"Specify Status" is
Provided.
Nov-09-2020
15:04:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLET
EDChanged
Information
Oct-22-2020
03:01:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Cl
osedResponse satisfies
query
Oct-20-2020
09:00:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Cl
osedClose Auto Query
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930413
Page 116 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-20-2020
09:00:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: An
sweredper query
Oct-20-2020
09:00:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERper query
Oct-20-2020
09:00:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Op
enedResponse to
"Status" is SCREEN
FAILURE but
"Specify Status" is
Provided.
Oct-20-2020
05:25:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Op
enedDM: Please update
any one
Inclusion/Exclusion
Criteria as not met,
or update Screening
Disposition Status to
OTHER and provide
a response for
Specify Status.
Oct-19-2020
09:56:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Cl
osedResponse satisfies
query
Oct-16-2020
08:28:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: An
swereda DCR was
submitted on 15 Sep
2020 to deactivate
impala subject
Oct-15-2020
14:22:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Cl
osedResponse satisfies
query
Oct-15-2020
09:31:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 4: Op
enedAs per Impala,
Subject status is
Active. Please
review and update
as appropriate.
Thank you.
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930414
Page 117 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-14-2020
09:57:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: An
sweredAnswer Auto Query
Oct-14-2020
04:01:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Cl
osedAdded to tracker
‘C4591001_list of
issue for Impala
update’.
Oct-14-2020
03:42:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edDM: Thank you for
response. Please
confirm if subject is
screen failure if yes
then remove
response to field
‘Specify Status:’ on
this page and update
CRF. Else clarify.
Oct-13-2020
08:46:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: An
sweredChanged data per
query
Oct-13-2020
08:46:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredChanged data per
query
Oct-13-2020
08:46:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Op
enedResponse to
"Status" is SCREEN
FAILURE but
"Specify Status" is
Provided.
Oct-10-2020
05:26:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Sandip Namdeorao
SuryawanshiQuery 2: Re
issued:Open
edKindly provide
screen failure reason
on specify status.
Thank you.
Oct-10-2020
05:25:40
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Sandip Namdeorao
SuryawanshiQuery 1: Cl
osedResponse satisfies
query
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930415
Page 118 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada)
Oct-08-2020
13:05:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredSubject was
randomized but then
experienced an AE
of Vomiting and
pre-syncope after
blood drawn.
Subject was screen
failed due to adverse
events ending visit 1
with no vaccination.
Subject was then
rescreened and
enrolled as subject
1122-1032.
Oct-08-2020
13:04:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredSubject experienced
an AE of Vomiting
and pre-syncope
after blood drawn.
Subject was screen
failed due to adverse
events. Subject was
then rescreened and
enrolled as subject
1122-1032.
Oct-08-2020
07:25:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Op
enedDM: Randomization
details present in
Impala but
Screening
Disposition Status is
not “Completed”.
Please correct as
appropriate and
capture
randomization
details in CRF.
Oct-07-2020
16:04:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Op
enedSubject is a screen
failure, but
Inclusion/Exclusion
criteria CRF is
marked as NOT
APPLICABLE.
Please complete
Inclusion/exclusion
criteria CRF with
the details of the
criteria not met by
the subject. Else
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930416
Page 119 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
clarify.
Sep-25-2020
10:04:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SCREEN F
AILUREInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-09-2020 15:04:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Changed Information
Oct-20-2020 09:00:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Status screen failure, subject experie
nced an AE of Vomiting and pre-syn
cope after blood drawn.Initial Entry
Oct-14-2020 09:57:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: changed per query
Oct-13-2020 08:46:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subject was randomized but then ex
perienced an AE of Vomiting and pr
e-syncope after blood drawn.Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930417
Page 120 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Weight:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Unit:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Height:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Unit:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7.a
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930418
Page 121 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7.a Temperature:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7.a Unit:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-09-2020 15:11:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930419
Page 122 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-09-2020 15:05:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-09-2020 15:05:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
87404Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930420
Page 123 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021 10:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
Feb-11-2021 10:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021 10:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Feb-11-2021 10:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-11-2021 10:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-11-2021 10:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Feb-11-2021 10:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930421
Page 124 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep/11/2020
Feb-11-2021 10:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-11-2021 10:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Feb-11-2021 10:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHC0WDInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-11-2021 10:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHC0WDInitial Entry
5.b
Date Location User Value Reason
Feb-11-2021 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHC0WFInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930422
Page 125 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Sample ID
Date Location User Value Reason
Feb-11-2021 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHC0WFInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930423
Page 126 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-09-2020 15:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-09-2020 15:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-09-2020 15:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-09-2020 15:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930424
Page 127 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-10-2020
23:44:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-10-2020
10:14:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredsubject was randomized but
not vaccinated
Nov-09-2020
22:15:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5328668;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930425
Page 128 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
appropriate.
Nov-09-2020
15:12:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930426
Page 129 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-09-2020 15:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930427
Page 130 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-09-2020 15:12:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930428
Page 131 of 152
***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: Incomplete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-09-2020 15:11:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:10:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-09-2020 15:13:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Nov-09-2020 15:11:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-09-2020 15:10:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930429
Page 132 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930430
Page 133 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930431
Page 134 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:39:09
(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
Sep-30-2020 03:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Sep-29-2020 13:46:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered One was not
completed. How
should we proceed?
Sep-28-2020 01:29:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Per protocol
section 8.1.,
COVID-19 listed
symptom
VOMITING should
have please triggered
a potential COVID
Visit irrespective of
possible etiology or
clinical significance.
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
vomitingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930432
Page 135 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020 15:39:09
(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
Sep-24-2020 13:09:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-24-2020 13:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930433
Page 136 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-24-2020 13:07:12
(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:
blood drawChanged Information
Sep-24-2020 13:02:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINREQUERY: This
field pertains only to
the STUDY Vaccine.
Per the query response
- "Event related to
study procedure, blood
draw", please consider
updating to NOT
RELATED - Study
Procedure Blood
Draw.
Sep-24-2020 13:01:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed need requery
Sep-24-2020 13:00:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINREQUERY: This
field pertains
specifically to the
Study Vaccine. Please
update.
Sep-24-2020 09:35:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Vax 1 not
administered. Event
related to study
procedure, blood draw.
Sep-23-2020 17:42:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Did
this Patient receive
Vaccine #1? If yes,
enter all applicable
CRFs. Otherwise,
please clarify AE -
VOMITING with
Study Treatment of
RELATED? Please
update or clarify.
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930434
Page 137 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:39:09
(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
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 15:59:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Sep-24-2020 09:33:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 09:33:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Sep-24-2020 06:24:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Did the adverse
event cause the subject
to be discontinued
from the study?' is Yes
but neither
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930435
Page 138 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as 'ADVERSE
EVENT'. Please
review and update as
appropriate. Thank
you.
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither DISPOSITION
- TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-22-2020 15:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930436
Page 139 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
pre-syncopeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930437
Page 140 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020 15:39:51
(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
Sep-24-2020 13:09:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-24-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Sep-24-2020 13:06:44
(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:
blood drawChanged Information
Sep-24-2020 13:02:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINREQUERY: This
field pertains only to
the STUDY Vaccine.
Per the query response
- "Event related to
study procedure, blood
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930438
Page 141 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
draw", please consider
updating to NOT
RELATED - Study
Procedure Blood
Draw.
Sep-24-2020 09:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject did not receive
vaccination. Events
were related to study
procedure, blood draw,
if this doesn't qualify
as treatment I will
change.
Sep-23-2020 17:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Did
this Patient receive
Vaccine #1? If yes,
enter all applicable
CRFs. Otherwise,
please clarify AE -
PRE-SYNCOPE with
Study Treatment of
RELATED? Please
update or clarify.
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930439
Page 142 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 15:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 17:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-16-2020 16:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered AEs were concurrent.
Both caused subject
to be discontinued
from study.
Nov-16-2020 16:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued from
the study?" marked as
'Yes'.
Nov-16-2020 16:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Oct-14-2020 03:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as data
updated.
Oct-13-2020 08:47:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Oct-13-2020 08:47:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-10-2020 05:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sandip Namdeorao
SuryawanshiQuery 1: Reissued:Opened DM3: If subject was
screen failure, kindly
update NO here. Else
clarify. Thank you.
Sep-30-2020 09:40:00
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered Subject was a screen
failure due to this AE
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0930440
Page 143 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) but remains in the
study after a
re-evaluation
screening visit was
completed. The
subject was
reassigned as subject
1122-1032
Sep-30-2020 05:05:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM2: Please confirm
if Subject is Screen
Failure or
discontinued due to
this AE and update
response to this
question or SCR
DISP page
accordingly.
Sep-29-2020 13:17:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Data is frozen
Sep-26-2020 02:33:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you for
the response.
However, Did the
adverse event cause
the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as 'ADVERSE
EVENT'.
Sep-25-2020 10:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Sep-25-2020 07:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930441
Page 144 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Status as 'ADVERSE
EVENT'. Please
review and update as
appropriate. Thank
you.
Sep-25-2020 06:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Data updated.
Sep-24-2020 09:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-24-2020 09:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Original value is
correct
Sep-24-2020 06:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as 'ADVERSE
EVENT'. Please
review and update as
appropriate. Thank
you.
Sep-24-2020 06:22:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM: Thank you for
the response however
please consider to
mark 'Did the adverse
event cause the
subject to be
discontinued from the
study?' as Yes for
only one AE which is
primary reason for
study discontinuation.
Else clarify.
Sep-23-2020 10:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject experienced
pre-syncope AND
vomiting
concurrently. Terms
were separated per
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930442
Page 145 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
protocol and recorded
as separate events.
Sep-22-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued from
the study?" marked as
'Yes'.
Sep-22-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-22-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930443
Page 146 of 152
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-09-2020 15:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-09-2020 15:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020 10:08:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 5: Closed CLosed as per study
team discussion
Nov-17-2020 08:42:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Apologies, subject
WAS discontinued.
Nov-16-2020 21:26:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Reissued:Opened DM Q: If subject did
not discontinue from
the study please remove
all the data from the
form.
Nov-16-2020 21:07:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-16-2020 14:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Subject was not
discontinued from
study
Nov-16-2020 14:44:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Closed Close Auto Query
Nov-16-2020 14:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened Response to "Status" is
ADVERSE EVENT but
"Specify Status" is
Provided.
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0930444
Page 147 of 152
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-16-2020 14:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause the
subject to be
discontinued from the
study' reported as YES.
Please check and
correct the data.
Nov-16-2020 14:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered changed per query
Nov-16-2020 14:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTchanged per query
Nov-16-2020 13:26:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened Page is unfrozen.
Nov-16-2020 08:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered please unfreeze crf to
allow appropriate
update.
Nov-16-2020 07:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SPECIFY STATUS
COMMENT="Subject
was not vaccinated
because he experienced
vomiting & syncope
following blood draw"
& same AEs are
reported in AE CRF.
Please consider
selecting ADVERSE
EVENT as
DISPOSITION-F/U
STATUS & removing
SPECIFY STATUS
COMMENT.
Nov-09-2020 15:24:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-09-2020 15:24:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-09-2020 15:24:25
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
OTHERChanged Information
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930445
Page 148 of 152
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
Nov-09-2020 15:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status" is
ADVERSE EVENT but
"Specify Status" is
Provided.
Nov-09-2020 15:23:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause the
subject to be
discontinued from the
study' reported as YES.
Please check and
correct the data.
Nov-09-2020 15:23:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Nov-09-2020 15:15:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-09-2020 15:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status" is
COMPLETED but
"Specify Status" is
Provided.
Nov-09-2020 15:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-16-2020 14:44:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: changed per query
Nov-09-2020 15:24:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subject was not vaccinated because
he experienced vomiting and syncop
e following blood draw.Initial Entry
Nov-09-2020 15:15:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Nov-09-2020 15:07:39 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930446
Page 149 of 152
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern Time
(US & Canada)subject not vaccinated because of vo
miting and syncope following blood
draw
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930447
Page 150 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-16-2020 14:43:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDchanged per query
Nov-09-2020 15:24:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-09-2020 15:23:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-09-2020 15:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COMPLETEDInitial Entry
Nov-09-2020 15:05:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-09-2020 15:04:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDChanged Information
Oct-20-2020 09:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREEN FAILper query
Sep-25-2020 10:04:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREEN FAILInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-16-2020 14:43:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020changed per query
Nov-09-2020 15:24:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Changed Information
Nov-09-2020 15:23:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Changed Information
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930448
Page 151 of 152
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-09-2020 15:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
Nov-09-2020 15:05:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
Nov-09-2020 15:04:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Changed Information
Oct-20-2020 09:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020per query
Sep-25-2020 10:04:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930449
Page 152 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-16-2020 16:20:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Margaret
TiktinData Entry:
Click Here to EnableInitial Entry
090177e196ae3030\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930450