125742 S1 M5 CRF c4591001 1232 12321175

Document text

Page 1 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989623
Page 2 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989624
Page 3 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Demography
1.Subject ID [12321175]
2.Birth Date: 1971
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:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989625
Page 4 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989626
Page 5 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989627
Page 6 of 161
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989628
Page 7 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989629
Page 8 of 161
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [344.0]
3.Unit: LB
4.Height: [78.0]
5.Unit: in
6.Body Mass Index: [39.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989630
Page 9 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [79556]
3.Randomization Group: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989631
Page 10 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP206Y]
5.bSample ID [BP206Z]
5.cSample ID [BP2070]
5.dSample ID [BNW9P3]
5.eSample ID [BNW9P4]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989632
Page 11 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYG55]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989633
Page 12 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/3/2020 09:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989634
Page 13 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989635
Page 14 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989636
Page 15 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989637
Page 16 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Inadvertently missed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989638
Page 17 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989639
Page 18 of 161
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989640
Page 19 of 161
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0H8L]
5.bSample ID [BR0H8M]
5.cSample ID [BR0H8N]
5.dSample ID [BS61P9]
5.eSample ID [BS61PB]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989641
Page 20 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989642
Page 21 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989643
Page 22 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989644
Page 23 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989645
Page 24 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989646
Page 25 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989647
Page 26 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989648
Page 27 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989649
Page 28 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989650
Page 29 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989651
Page 30 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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?
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989652
Page 31 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989653
Page 32 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989654
Page 33 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989655
Page 34 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989656
Page 35 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Unplanned Assessments
1.Assessments
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989657
Page 36 of 161
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989658
Page 37 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989659
Page 38 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989660
Page 39 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989661
Page 40 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  high blood pressu
re Sep/25/2020 00:
00 NO
End Date Time:
Oct/23/2020 00:00
 Repeating
Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989662
Page 41 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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)[high blood pressure]
4.Start Date Time: Sep/25/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/23/2020 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989663
Page 42 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989664
Page 43 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989665
Page 44 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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[ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989666
Page 45 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989667
Page 46 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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: //
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989668
Page 47 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989669
Page 48 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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?
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989670
Page 49 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989671
Page 50 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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?
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989672
Page 51 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989673
Page 52 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989674
Page 53 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989675
Page 54 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989676
Page 55 of 161
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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?
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989677
Page 56 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989678
Page 57 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989679
Page 58 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989680
Page 59 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989681
Page 60 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989682
Page 61 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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 [ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989683
Page 62 of 161
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989684
Page 63 of 161
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989685
Page 64 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989686
Page 65 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Done
//Comments
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989687
Page 66 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989688
Page 67 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/25/2020
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989689
Page 68 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989690
Page 69 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989691
Page 70 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-03-2020 09:52:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989692
Page 71 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-03-2020 09:53:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989693
Page 72 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-25-2020 15:25:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989694
Page 73 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Sep-25-2020 15:25:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989695
Page 74 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aSep-25-2020 15:25:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989696
Page 75 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aSep-25-2020 15:25:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989697
Page 76 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aSep-25-2020 15:25:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989698
Page 77 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989699
Page 78 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989700
Page 79 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989701
Page 80 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989702
Page 81 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Sep-25-2020 15:27:27 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989703
Page 82 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989704
Page 83 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989705
Page 84 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
7Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989706
Page 85 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
8Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989707
Page 86 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
9Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989708
Page 87 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
10Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989709
Page 88 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
11Sep-25-2020 15:28:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989710
Page 89 of 161
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormMar-09-2021 13:39:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
FormMar-09-2021 13:35:58 (UTC-05:00) Eastern Time
(US & Canada)
FormMar-08-2021 16:47:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989711
Page 90 of 161
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Mar-09-2021 13:39:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Mar-09-2021 13:35:58 (UTC-05:00) Eastern Time
(US & Canada)
1Mar-08-2021 16:47:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989712
Page 91 of 161
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Mar-09-2021 13:39:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2Mar-09-2021 13:35:58 (UTC-05:00) Eastern Time
(US & Canada)
2Mar-08-2021 16:47:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989713
Page 92 of 161
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Mar-09-2021 13:39:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
3Mar-09-2021 13:35:58 (UTC-05:00) Eastern Time
(US & Canada)
3Mar-08-2021 16:47:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989714
Page 93 of 161
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Mar-09-2021 13:39:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Mar-09-2021 13:35:58 (UTC-05:00) Eastern Time
(US & Canada)
4Mar-08-2021 16:47:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989715
Page 94 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormMar-09-2021 13:39:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
FormMar-05-2021 12:56:31 (UTC-05:00) Eastern Time
(US & Canada)Participant is not eligible.
FormMar-03-2021 15:52:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989716
Page 95 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Mar-09-2021 13:39:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Mar-05-2021 12:56:31 (UTC-05:00) Eastern Time
(US & Canada)Participant is not eligible.
1Mar-03-2021 15:52:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989717
Page 96 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormMar-05-2021 12:57:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989718
Page 97 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Mar-05-2021 12:57:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989719
Page 98 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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-26-2021 08:50:25 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-25-2021 14:36:14 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-21-2021 10:20:14 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 10:38:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-11-2020 09:53:22 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989720
Page 99 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Affidavit:
N/A
 Approved Dec-03-2020 08:17:37 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-02-2020 18:15:06 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley  Approved Dec-02-2020 15:07:05 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyKingsley, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-01-2020 16:09:05 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-01-2020 11:14:55 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989721
Page 100 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-30-2020 18:34:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 15:04:15 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 08:45:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley  Approved Nov-09-2020 09:35:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyKingsley, 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.
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989722
Page 101 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
 N/A Nov-06-2020 10:02:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley  Approved Nov-05-2020 09:37:45 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyKingsley, 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.
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989723
Page 102 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 09:51:55
(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-03-2020 09:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989724
Page 103 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 09:52:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989725
Page 104 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 09:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12321175Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 09:51:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 09:52:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 09:52:36
(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-03-2020 09:52:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989726
Page 105 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 09:52:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989727
Page 106 of 161
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 09:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 09:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 09:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989728
Page 107 of 161
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020 04:05:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-08-2020 09:22:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Data confirmed as is,
not clinically
significant.
Sep-04-2020 23:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: The reported
weight value 344.0
lb is out of range.
Kindly review and
confirm if it is
clinically significant
or not.
Sep-03-2020 10:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-03-2020 09:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 344 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for lb.
Sep-03-2020 09:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
344.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989729
Page 108 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
4. Height:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
78.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
39.7Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989730
Page 109 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
7.a Unit:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 09:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989731
Page 110 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 10:02:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 10:02:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
79556Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989732
Page 111 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 10:07:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 10:07:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 10:07:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 10:06:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP206YInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 10:06:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP206YInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 10:06:27
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989733
Page 112 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada) Sample ID: BP206Z
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 10:06:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP206ZInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 10:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP2070Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 10:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP2070Initial Entry
5.d
Date Location User Value Reason
Sep-03-2020 10:06:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW9P3Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 10:06:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNW9P3Initial Entry
5.e
Date Location User Value Reason
Sep-03-2020 10:07:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW9P4Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989734
Page 113 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 10:07:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNW9P4Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989735
Page 114 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 10:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 10:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 10:08:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 10:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-03-2020 10:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 10:08:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYG55Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989736
Page 115 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Sep-03-2020 10:08:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYG55Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989737
Page 116 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020 09:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989738
Page 117 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
7. Route:
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-03-2020 10:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989739
Page 118 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 10:02:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989740
Page 119 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 15:21:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989741
Page 120 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 22:34:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-29-2020 08:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No V2 due to BP
150/113
Sep-28-2020 20:35:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
confirm temp not
taken at VAX 2 visit
or update as
appropriate.
Sep-25-2020 15:25:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Sep-25-2020 15:25:49
(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
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 15:25:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 15:25:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989742
Page 121 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.a Unit:
Date Location User Value Reason
Sep-25-2020 15:25:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 15:25:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989743
Page 122 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-25-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inadvertently missedInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989744
Page 123 of 161
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 15:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989745
Page 124 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
7. Route:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 15:28:02
(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
Sep-25-2020 15:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989746
Page 125 of 161
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 16:46:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Mar-08-2021 16:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Jan-22-2021 10:02:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-21-2021 10:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Jan-08-2021 08:40:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-08-2021 08:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Oct-26-2020 09:04:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989747
Page 126 of 161
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 09:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 09:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 09:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 09:04:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0H8LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 09:04:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0H8LInitial Entry
5.b
Date Location User Value Reason
Oct-26-2020 09:04:56
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989748
Page 127 of 161
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada) Sample ID: BR0H8M
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 09:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0H8MInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 09:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0H8NInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 09:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0H8NInitial Entry
5.d
Date Location User Value Reason
Oct-26-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS61P9Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-26-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS61P9Initial Entry
5.e
Date Location User Value Reason
Oct-26-2020 09:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS61PBInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989749
Page 128 of 161
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e Sample ID
Date Location User Value Reason
Oct-26-2020 09:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS61PBInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989750
Page 129 of 161
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-01-2020 16:09:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020New Information
Oct-26-2020 09:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 09:05:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-02-2020
16:30:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 8:
ClosedAuto closed by
Validation Check:
VC_DS001_25
Dec-02-2020
09:10:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 8:
AnsweredAE log has been
updated
Dec-01-2020
21:17:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 8:
OpenedDMW6288819;Status
is reported as
Adverse Event, but
there is no Adverse
Event with 'Latest
Action Taken with
Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as appropriate.
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989751
Page 130 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Dec-01-2020
16:09:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7:
ClosedClose Auto Query
Dec-01-2020
16:09:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7:
OpenedResponse to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Dec-01-2020
16:09:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
ADVERS
E EVENTNew Information
Nov-13-2020
03:47:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5:
ClosedResponse satisfies
query
Nov-12-2020
08:45:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6:
ClosedClose Auto Query
Nov-12-2020
08:45:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6:
OpenedResponse to "Status"
is OTHER but
"Specify Status" is
missing.
Nov-12-2020
08:45:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5:
AnsweredTranscription Error
Nov-12-2020
08:45:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
OTHERTranscription Error
Nov-12-2020
06:00:32
(UTC-05:00)ACV0PFEINFP6000  Balaji Prabu R Query 5:
OpenedStatus is reported as
COMPLETED, but
this subject not
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989752
Page 131 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time
(US & Canada)received vaccination
2. If this is correct,
status cannot be
COMPLETED as per
completion
guidelines. Please
verify and enter the
correct status.
Nov-07-2020
13:23:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4:
ClosedResponse satisfies
query
Nov-07-2020
12:00:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4:
AnsweredInitial Entry
Nov-07-2020
12:00:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
COMPLE
TEDInitial Entry
Nov-07-2020
02:46:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 4:
OpenedPlease enter correct
status in this CRF.
Nov-06-2020
10:02:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:Transcription Error
Nov-04-2020
11:17:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3:
ClosedClose Auto Query
Nov-04-2020
11:17:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
COMPLE
TEDTranscription Error
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989753
Page 132 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-04-2020
10:40:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2:
ClosedResponse satisfies
query
Nov-04-2020
08:28:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3:
OpenedResponse to "Status"
is LOST TO
FOLLOW-UP but
"Specify Status" is
missing.
Nov-04-2020
08:28:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
AnsweredTranscription Error
Nov-04-2020
08:28:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
LOST TO
FOLLOW
-UPTranscription Error
Nov-04-2020
07:27:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 2:
OpenedSubject has not
received vaccination
2, but status of end of
treatment disposition
is entered as
COMPLETED.
Please verify and
update accordingly,
else clarify. Thank
you.
Nov-04-2020
00:30:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies
query
Nov-03-2020
08:54:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1:
AnsweredChanged data per
query
Nov-02-2020
13:47:42
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Balaji Prabu R Query 1:
OpenedDM: Per completion
guidelines, ’If the
Participant receives
all vaccinations as per
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989754
Page 133 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada) protocol and
completes follow-up
visit procedures
within 1-month post
vaccination period,
report status as
COMPLETED’.
Kindly review and
update CRF as
needed. Else clarify
Oct-26-2020
09:05:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
COMPLE
TEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Dec-02-2020 11:09:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Dec-02-2020 11:09:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Dec-02-2020 09:10:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered AE log has been
updated
Dec-02-2020 09:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: AE
not yet reported
under Logs tab.
Please review and
update
Dec-01-2020 16:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: New Information
Dec-01-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered AE has been created
and EOT has been
updated with
Adverse Event.
Dec-01-2020 05:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: High
BP has not been
captured as an
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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)
(b) (4)
FDA-CBER-2021-5683-0989755
Page 134 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
adverse event (no
MedHx reported).
Please review and
update AE listing.
Reason for EOT then
to be captured with
status selection
'ADVERSE EVENT'
Nov-30-2020 18:34:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer to query
Nov-30-2020 18:34:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer to query
Nov-30-2020 18:34:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject did not received Vaccinat
ion 2 due to blood pressure being
too high.Answer to query
Nov-30-2020 11:51:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY: In the
V2 folder: 'No V2
due to BP 150/113'.
Please review if this
refers to an adverse
event. No AEs have
been reported for this
subject
Nov-30-2020 11:48:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Please
clarify in this field
why subject did not
receive vax 2. Status
selection in field
above is 'OTHER' -
please review if that
selection is correct
per CRF guidelines
Nov-12-2020 08:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject did not received Vaccinat
ion 2Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989756
Page 135 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-09-2021 13:39:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 13:35:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-08-2021 16:47:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-08-2021 16:46:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
Mar-05-2021 09:33:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-22-2021 10:02:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020Transcription Error
Jan-21-2021 10:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
Jan-10-2021 23:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-08-2021 08:40:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-08-2021 08:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Initial Entry
Jan-08-2021 08:09:28
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989757
Page 136 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada)
Jan-08-2021 02:24:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Subject
discontinued, kindly
update as per given
guidelines. "If the
Participant,
discontinues during
the treatment period
and does not agree to
remain in the study
for follow-up, report
the same status/date
as reported on
Disposition
Treatment form.
Dec-14-2020 08:11:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Dec-14-2020 08:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-14-2020 08:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-14-2020 01:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY: Thank
you for confirming
future visits will be
completed. Please
update page to match
i.e. remove entries
Dec-11-2020 11:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissued:Candidate CLINQUERY: Thank
you for confirming
future visits will be
completed. Please
update page to match
i.e. remove entries
Dec-11-2020 09:52:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject will attend
future visits.
Dec-11-2020 09:31:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: End
of study is reported
due to an AE on
23Oct20. please
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989758
Page 137 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
review and confirm
this information is
correct. The linked
AE is reported to end
23Oct20 and V3
occurred same day.
Will subject no
longer attend any
future visits?
Dec-02-2020 18:15:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-09-2021 13:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-09-2021 13:35:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Mar-08-2021 16:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-08-2021 16:46:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Mar-05-2021 09:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-21-2021 10:20:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Jan-08-2021 08:40:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-08-2021 08:09:28
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989759
Page 138 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
Dec-14-2020 08:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-02-2020 18:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-09-2021 13:39:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 13:35:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-08-2021 16:47:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-08-2021 16:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
Mar-05-2021 09:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Mar-05-2021 09:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-05-2021 09:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "Status"
is NO LONGER
MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Jan-21-2021 10:21:41
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989760
Page 139 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada)
Jan-21-2021 10:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Status"
is NO LONGER
MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Jan-21-2021 10:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Jan-21-2021 10:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO LONGER MEETS ELIGIBI
LITY CRITERIATranscription Error
Jan-21-2021 10:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: 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.
Jan-21-2021 10:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
Jan-08-2021 08:12:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-08-2021 08:12:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-08-2021 08:09:28
(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.
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989761
Page 140 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-08-2021 08:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989762
Page 141 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
3. Status:
Date Location User Value Reason
Dec-15-2020 01:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-14-2020 08:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Dec-14-2020 08:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-14-2020 00:26:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: This form has
been unfrozen.
Please review and
update the status of
the subject
accordingly else
clarify.
Dec-11-2020 09:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Entered in error.
Subject will continue
with study
Dec-11-2020 09:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: 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.
Dec-02-2020 18:15:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-10-2021 04:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989763
Page 142 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Mar-09-2021 13:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject will remain
in trial. Incorrect
data points have been
corrected.
Mar-09-2021 13:39:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 13:35:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-08-2021 17:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissued:Opened CLINQUERY:
Please clarify in
query response if
subject remains on
trial or not. Page
updates not clear. If
subject will no
longer participate in
further visits, please
update page to reflect
date for end of study
and status/reason for
end
Mar-08-2021 16:47:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-08-2021 16:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-08-2021 16:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject withdrew consent from st
udyInitial Entry
Mar-08-2021 14:30:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Page
cleared - please
confirm that subject
will remain in study
and participate in
future visits
Mar-05-2021 09:32:16 ACV0PFEINFP6000  auto query Query 1: Answered Transcription Error
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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)
FDA-CBER-2021-5683-0989764
Page 143 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00) Eastern
Time (US & Canada)(autoquery)
Mar-05-2021 09:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-04-2021 04:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please review the
reason added for end
of study. Despite no
Vax 2, subject did
attend the V3 follow
up. If subject will not
attend any further
follow ups, please
apply a status
selection to match
reason
Mar-03-2021 17:44:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Candidate CLINQUERY:
Please review the
reason added for end
of study. Despite no
Vax 2, subject did
attend the V3 follow
up. If subject will not
attend any further
follow ups, please
apply a status
selection to match
reason
Jan-21-2021 10:21:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject did did not take V2.Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989765
Page 144 of 161
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989766
Page 145 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Category:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
high blood pressureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Jan-22-2021
15:32:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Jan-22-2021
10:03:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989767
Page 146 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6942649;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Dec-02-2020
09:09:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NO
End
Date
Tim
e:
Oc
t/2
3/2
02
0 0
0:0
0Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-02-2020 09:09:44
(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
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989768
Page 147 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-02-2020 09:09:44
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989769
Page 148 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-11-2020 11:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed confirmed follow up
will continue, FUP
page to be amended
Dec-11-2020 09:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Dec-02-2020 18:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered FUP has been
updated
Dec-02-2020 11:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: This
field indicates subject
has ceased
participation in trial
and will no longer be
followed/no further
visits will occur. If
entry is correct,
please update FUP
tab. Else, if subject
will continue in FUP,
please update.
Dec-02-2020 09:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989770
Page 149 of 161
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-08-2021
16:46:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Clo
sedClose Auto Query
Mar-08-2021
16:44:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Op
enedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Mar-05-2021
14:08:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Mar-05-2021
10:47:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredRevax form updated
Mar-05-2021
10:46:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Del
etedClose Auto Query
Mar-05-2021
09:55:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: REVAX CONT forms
have been unfrozen for data
update. Thank you.
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989771
Page 150 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Mar-04-2021
21:35:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unfreeze REVAX
form so that data can be
corrected. Thank you.
Mar-04-2021
21:35:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Can
didateErroneous Visit is marked,
but date of visit is entered.
Please either untick the
erroneous visit button if
visit occurred, or mark any
forms containing data
within this visit as Not
Done/Not Applicable at the
form level.
Mar-04-2021
08:39:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Mar-03-2021
15:01:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredThis tab was filled out
incorrectly. The subject is
not deceased. The N/A
button was chosen in error.
Feb-26-2021
18:31:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7479095;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-26-2021
09:01:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Feb-26-2021
09:01:32
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data
Entry
:
Feb/9/Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989772
Page 151 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US &
Canada)2021
2. Erroneous Visit
Date Location User Value Reason
Mar-05-2021 10:46:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-04-2021 21:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989773
Page 152 of 161
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-26-2021 09:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989774
Page 153 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Mar-05-2021
15:13:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Rivkah Rosen Query
1: Clo
sedResponse satisfies query
Mar-05-2021
12:57:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
Mar-05-2021
12:53:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM RQ: Please confirm
which form is required for
unfreezing.
Mar-04-2021
21:36:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unfreeze form so that
data can be corrected.
Thank you.
Feb-26-2021
19:25:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7479319;‘Date
Treatment Unblinded' is
after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-26-2021
08:50:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/9/
2021Initial Entry
2. Primary Reason for Unblinding:
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989775
Page 154 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Feb-26-2021 08:50:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989776
Page 155 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Mar-09-2021 13:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 13:39:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-05-2021 12:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
Mar-05-2021 12:56:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-03-2021 15:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (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-2021-5683-0989777
Page 156 of 161
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-05-2021 12:57:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989778
Page 157 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-08-2021 16:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Mar-05-2021 09:32:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Jan-21-2021 10:20:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Jan-21-2021 10:20:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Jan-08-2021 08:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Jan-08-2021 08:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Dec-14-2020 08:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Dec-02-2020 18:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Dec-01-2020 16:09:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDNew Information
Nov-12-2020 08:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-07-2020 12:00:00
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989779
Page 158 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
Nov-06-2020 10:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDTranscription Error
Nov-04-2020 11:17:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPTranscription Error
Nov-04-2020 08:28:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-26-2020 09:05:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020 10:02:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-03-2020 09:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-08-2021 16:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Mar-08-2021 16:46:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Mar-08-2021 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Mar-05-2021 09:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Mar-05-2021 09:32:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Jan-22-2021 10:02:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Transcription Error
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989780
Page 159 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-21-2021 10:20:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Jan-21-2021 10:20:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Jan-08-2021 08:40:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Jan-08-2021 08:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Jan-08-2021 08:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Dec-14-2020 08:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Dec-14-2020 08:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Dec-02-2020 18:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
Dec-01-2020 16:09:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020New Information
Dec-01-2020 16:09:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020New Information
Nov-12-2020 08:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Transcription Error
Nov-07-2020 12:00:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
Nov-06-2020 10:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Transcription Error
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989781
Page 160 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-04-2020 11:17:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Transcription Error
Nov-04-2020 08:28:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Transcription Error
Oct-26-2020 09:05:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
Sep-03-2020 10:02:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
Sep-03-2020 09:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989782
Page 161 of 161
***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: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-05-2020 09:37:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Jeffrey
KingsleyData Entry:
Click Here to EnableInitial Entry
090177e196ae3000\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989783