125742 S1 M5 CRF c4591001 1232 12321299

Document text

Page 1 of 141
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990157
Page 2 of 141
***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: 12321299 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
Oct/6/2020
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990158
Page 3 of 141
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Demography
1.Subject ID [12321299]
2.Birth Date: 1965
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990159
Page 4 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990160
Page 5 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990161
Page 6 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990162
Page 7 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Undiagnosed Hypertension]
Start Date: Oct/6/2020
Ongoing: YES
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990163
Page 8 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [23.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990164
Page 9 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/6/2020
2.Randomization Number: [103758]
3.Randomization Group: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990165
Page 10 of 141
***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: 12321299 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/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8K9X]
5.bSample ID [BR8K9Y]
5.cSample ID [BR8K9Z]
5.dSample ID [BNTLDK]
5.eSample ID [BNTLDL]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990166
Page 11 of 141
***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: 12321299 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:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8K9C]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990167
Page 12 of 141
***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: 12321299 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: Oct/6/2020 10:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990168
Page 13 of 141
***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: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990169
Page 14 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990170
Page 15 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990171
Page 16 of 141
***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, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990172
Page 17 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
ObservedNot Done Comments
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990173
Page 18 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990174
Page 19 of 141
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990175
Page 20 of 141
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990176
Page 21 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990177
Page 22 of 141
***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: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990178
Page 23 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990179
Page 24 of 141
***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: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990180
Page 25 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990181
Page 26 of 141
***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: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990182
Page 27 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990183
Page 28 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990184
Page 29 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990185
Page 30 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990186
Page 31 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990187
Page 32 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990188
Page 33 of 141
***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: 12321299 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:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990189
Page 34 of 141
***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: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990190
Page 35 of 141
***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: 12321299 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:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990191
Page 36 of 141
***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: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990192
Page 37 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990193
Page 38 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Unplanned Assessments
1.Assessments
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990194
Page 39 of 141
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990195
Page 40 of 141
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990196
Page 41 of 141
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990197
Page 42 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990198
Page 43 of 141
***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: 12321299 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[ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990199
Page 44 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990200
Page 45 of 141
***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: 12321299 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: //
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990201
Page 46 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990202
Page 47 of 141
***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: 12321299 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?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990203
Page 48 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990204
Page 49 of 141
***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: 12321299 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?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990205
Page 50 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990206
Page 51 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990207
Page 52 of 141
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: OTHER
4.Specify Status: [Subject did not receive V2 vaccination due to investigator
decision and was then lost to follow up]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990208
Page 53 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990209
Page 54 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12321299 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:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990210
Page 55 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990211
Page 56 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990212
Page 57 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990213
Page 58 of 141
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990214
Page 59 of 141
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990215
Page 60 of 141
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990216
Page 61 of 141
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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 [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990217
Page 62 of 141
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990218
Page 63 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990219
Page 64 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990220
Page 65 of 141
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990221
Page 66 of 141
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990222
Page 67 of 141
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990223
Page 68 of 141
***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: 12321299 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 Oct/6/2020
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990224
Page 69 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990225
Page 70 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12321299 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
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990226
Page 71 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-06-2020 10:02:11
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990227
Page 72 of 141
***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, Answered Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormMar-12-2021 14:52:03
(UTC-05:00) Eastern Time (US &
Canada)
FormOct-06-2020 10:02:43
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990228
Page 73 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormJan-27-2021 13:48:51 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990229
Page 74 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Jan-27-2021 13:48:51 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990230
Page 75 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Jan-27-2021 13:48:51 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990231
Page 76 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormJan-27-2021 13:49:02 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990232
Page 77 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Jan-27-2021 13:49:02 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990233
Page 78 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aJan-27-2021 13:49:02 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990234
Page 79 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aJan-27-2021 13:49:02 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990235
Page 80 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aJan-27-2021 13:49:02 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990236
Page 81 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormJan-27-2021 13:49:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990237
Page 82 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Jan-27-2021 13:49:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990238
Page 83 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Jan-27-2021 13:49:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990239
Page 84 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Jan-27-2021 13:49:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990240
Page 85 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Jan-27-2021 13:49:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990241
Page 86 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormJan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990242
Page 87 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990243
Page 88 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990244
Page 89 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990245
Page 90 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990246
Page 91 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990247
Page 92 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990248
Page 93 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
7Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990249
Page 94 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
8Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990250
Page 95 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
9Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990251
Page 96 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
10Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990252
Page 97 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
11Jan-27-2021 13:49:26 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990253
Page 98 of 141
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12321299 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 Jan-27-2021 13:48:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 14:02:53 (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.
Jeffrey
Kingsley Approved Nov-10-2020 14:02:51 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990254
Page 99 of 141
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
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.
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990255
Page 100 of 141
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
Oct-06-2020
10:01:27
(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
Oct-06-2020
10:01:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990256
Page 101 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-06-2020
10:01:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Oct/6/2020Initial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990257
Page 102 of 141
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020
10:01:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12321299Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-06-2020
10:01:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1965Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-06-2020
10:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990258
Page 103 of 141
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-06-2020
10:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-06-2020
10:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRI
CAN AMERICANInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990259
Page 104 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020
06:42:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Oct-08-2020
09:37:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dupdated
Oct-08-2020
01:53:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to
update
details on
SWAB TRK,
and SWAB
PFE forms or
else clarify.
Thank you.
Oct-06-2020
10:01:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae2fe8\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-2021-5683-0990260
Page 105 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
Oct-06-2020
10:02:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020
10:02:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020
10:02:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990261
Page 106 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.a
Date Location User Value Reason
Mar-12-2021
14:53:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:Undiagnos
ed Hyperte
nsion
Start Dat
e:Oct/6/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Mar-12-2021
14:53:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-12-2021
14:53:18
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Undiagnosed Hypert
ensionInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990262
Page 107 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Mar-12-2021
14:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Illness was
first noticed at
V1. Patient
was instructed
to see PCP.
Mar-12-2021
14:53:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 06/Oct
/2020. Please
review and
update as
appropriate.
Mar-12-2021
14:53:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Mar-12-2021
14:53:18ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe8\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-2021-5683-0990263
Page 108 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990264
Page 109 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae2fe8\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-2021-5683-0990265
Page 110 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
73.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.7Initial Entry
7.a
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Record Id 1Initial Entry
090177e196ae2fe8\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-2021-5683-0990266
Page 111 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US
& Canada)entifier::
Temperat
ure:37.4
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
37.4Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990267
Page 112 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-06-2020
10:03:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990268
Page 113 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-06-2020
10:03:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-06-2020
10:19:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
103758Initial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990269
Page 114 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
09:36:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
09:36:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
09:36:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/6/2020Initial Entry
5.a
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990270
Page 115 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-08-2020
09:35:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8K9
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
09:35:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8K9XInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020
09:35:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8K9
YInitial Entry
090177e196ae2fe8\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-2021-5683-0990271
Page 116 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.b Sample ID
Date Location User Value Reason
Oct-08-2020
09:35:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8K9YInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020
09:35:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8K9
ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020
09:35:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8K9ZInitial Entry
5.d
Date Location User Value Reason
090177e196ae2fe8\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-2021-5683-0990272
Page 117 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-08-2020
09:36:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNTL
DKInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-08-2020
09:36:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNTLDKInitial Entry
5.e
Date Location User Value Reason
Oct-08-2020
09:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNTL
DLInitial Entry
090177e196ae2fe8\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-2021-5683-0990273
Page 118 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e Sample ID
Date Location User Value Reason
Oct-08-2020
09:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNTLDLInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990274
Page 119 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
09:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
09:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
09:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/6/2020Initial Entry
5.a
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990275
Page 120 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-08-2020
09:36:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8K9
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
09:36:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8K9CInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990276
Page 121 of 141
***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: 12321299 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
Oct-06-2020
10:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990277
Page 122 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 10:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020
10:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990278
Page 123 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020
10:43:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-06-2020
10:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990279
Page 124 of 141
***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: 12321299 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
Oct-06-2020
10:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990280
Page 125 of 141
***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, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021
13:48:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-27-2021
13:48:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990281
Page 126 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::Not
Done
Temperatur
e:Not
Done
Temperatur
e Unit:Not
Done
Temperatur
e Location::Not
DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\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-2021-5683-0990282
Page 127 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
& Canada)
2.a Temperature:
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-27-2021
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\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-2021-5683-0990283
Page 128 of 141
***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, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021
13:49:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021
13:49:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
13:49:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae2fe8\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-2021-5683-0990284
Page 129 of 141
***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, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Jan-27-2021
13:49:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990285
Page 130 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fe8\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-2021-5683-0990286
Page 131 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\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-2021-5683-0990287
Page 132 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-27-2021
13:49:26
(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
090177e196ae2fe8\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-2021-5683-0990288
Page 133 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-27-2021
13:49:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990289
Page 134 of 141
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 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
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021
16:09:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissu
ed:OpenedCLINQUERY:
Per comment on
page, please
review if EOT
reason was for
status
PHYSICIAN
DECISION and
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990290
Page 135 of 141
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
consider if
subject should
also be reported
off study (FUP
page) due to
LTFU comment
Mar-12-2021
15:00:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredData has been
updated
Mar-12-2021
14:32:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissu
ed:OpenedCLINQUERY:
MH is unlocked
as requested -
please ensure any
entry added is
related to
events/conditions
prior to V1.
Mar-11-2021
14:09:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredPlease unlock
Med Hx.
Temporary delay
was initially
intended.
Mar-10-2021
13:39:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissu
ed:OpenedCLINQUERY:
For high BP -
there is no
adverse event
entry nor prior
med hx for this
090177e196ae2fe8\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-2021-5683-0990291
Page 136 of 141
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
occurrence.
Please review if
one of the
listings needs
updating. Per
your information
was a temporary
delay initially
intended?
Mar-10-2021
10:32:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredPt blood pressure
was too high to
receive
vaccination
Mar-10-2021
04:53:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissu
ed:OpenedCLINQUERY:
Please clarify
reason for lack of
Vax 2 - per
comment
'investigator
decision'. Was
any event linked
to this decision?
Mar-08-2021
12:39:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredEOT date is
correct
Mar-03-2021
02:24:45ACV0PFEINFP6000  Query 1: Opene
dCLINQUERY:
Please review
090177e196ae2fe8\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-2021-5683-0990292
Page 137 of 141
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time
(US & Canada)reason for not
administering
Vax2 and select a
status that
matches that
reason. Please
also review EOT
date since should
match to the date
of decision not to
dose at Vax 2
(currently is V1
date)
Mar-02-2021
12:26:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Candi
dateCLINQUERY:
Please review
reason for not
administering
Vax2 and select a
status that
matches that
reason. Please
also review EOT
date since should
match to the date
of decision not to
dose at Vax 2
(currently is V1
date)
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990293
Page 138 of 141
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Queries, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
4. Specify Status:
Date Location User Value Reason
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subject did not recei
ve V2 vaccination d
ue to investigator de
cision and was then l
ost to follow upInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990294
Page 139 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-06-2020
10:03:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-06-2020
10:02:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-27-2021
13:52:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Oct-06-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990295
Page 140 of 141
***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: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
10:03:53
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Oct/6/2020
Oct-06-2020
10:02:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990296
Page 141 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321299 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
10:01:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Enab
leInitial Entry
090177e196ae2fe8\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990297