125742 S1 M5 CRF c4591001 1232 12321159

Document text

Page 1 of 128
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989495
Page 2 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989496
Page 3 of 128
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Demography
1.Subject ID [12321159]
2.Birth Date: 1998
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989497
Page 4 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989498
Page 5 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989499
Page 6 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989500
Page 7 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ADHD]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989501
Page 8 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [170.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [28.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989502
Page 9 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989503
Page 10 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [76558]
3.Randomization Group: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989504
Page 11 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP205B]
5.bSample ID [BP205C]
5.cSample ID [BP205D]
5.dSample ID [BNWBCP]
5.eSample ID [BNWBCR]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989505
Page 12 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BPYG4B]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989506
Page 13 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 09:20
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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989507
Page 14 of 128
***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: 12321159 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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989508
Page 15 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989509
Page 16 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989510
Page 17 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989511
Page 18 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP20T2]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989512
Page 19 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 16:19
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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989513
Page 20 of 128
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989514
Page 21 of 128
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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/21/2020
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 [BR2XYL]
5.bSample ID [BR2XYM]
5.cSample ID [BR2XYN]
5.dSample ID [BS61M8]
5.eSample ID [BS61M9]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989515
Page 22 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989516
Page 23 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989517
Page 24 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989518
Page 25 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989519
Page 26 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989520
Page 27 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989521
Page 28 of 128
***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: 12321159 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:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989522
Page 29 of 128
***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: 12321159 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: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989523
Page 30 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989524
Page 31 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989525
Page 32 of 128
***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: 12321159 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?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989526
Page 33 of 128
***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: 12321159 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:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989527
Page 34 of 128
***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: 12321159 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:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989528
Page 35 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989529
Page 36 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989530
Page 37 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Unplanned Assessments
1.Assessments
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989531
Page 38 of 128
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989532
Page 39 of 128
***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: 12321159 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: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989533
Page 40 of 128
***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: 12321159 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:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989534
Page 41 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989535
Page 42 of 128
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  exposure during
pregnancy Dec/28/2020
00:00 YES  Repeating
Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989536
Page 43 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[exposure during pregnancy]
4.Start Date Time: Dec/28/2020 00:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989537
Page 44 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989538
Page 45 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989539
Page 46 of 128
***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: 12321159 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[ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989540
Page 47 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989541
Page 48 of 128
***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: 12321159 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: //
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989542
Page 49 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989543
Page 50 of 128
***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: 12321159 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?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989544
Page 51 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatme
ntStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989545
Page 52 of 128
***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: 12321159 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?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989546
Page 53 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989547
Page 54 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989548
Page 55 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989549
Page 56 of 128
***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: 12321159 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:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989550
Page 57 of 128
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989551
Page 58 of 128
***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: 12321159 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?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989552
Page 59 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989553
Page 60 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989554
Page 61 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989555
Page 62 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989556
Page 63 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989557
Page 64 of 128
***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: 12321159 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 [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989558
Page 65 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989559
Page 66 of 128
***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: 12321159 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?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989560
Page 67 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989561
Page 68 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989562
Page 69 of 128
***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: 12321159 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: [ ]
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989563
Page 70 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989564
Page 71 of 128
***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: 12321159 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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989565
Page 72 of 128
***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: 12321159 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
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989566
Page 73 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-02-2020 09:37:03 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989567
Page 74 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-08-2021 11:46:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Kingsley Approved Oct-29-2020 09:07:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyKingsley, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend
that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0989568
Page 75 of 128
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020
09:36:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020
09:36:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989569
Page 76 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
09:36:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/2/2020Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989570
Page 77 of 128
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
09:36:10
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12321159Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
09:36:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1998Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
09:36:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020
09:36:45
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANIInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989571
Page 78 of 128
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US &
Canada)SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
09:36:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989572
Page 79 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020
09:36:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989573
Page 80 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020
09:37:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
09:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
09:37:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989574
Page 81 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
09:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ADHD
Start Date: UNK/UN
K/2011
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
09:37:48
(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
Sep-02-2020
09:37:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ADHDInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989575
Page 82 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Sep-02-2020
09:37:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
09:37:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989576
Page 83 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
170.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020
09:38:15ACV0PFEINFP6000  Data Entry:
65.0Initial Entry
090177e196ae3001\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-2021-5683-0989577
Page 84 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US &
Canada)
5. Unit:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.3Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:36.9
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
090177e196ae3001\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-2021-5683-0989578
Page 85 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
09:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3001\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-2021-5683-0989579
Page 86 of 128
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989580
Page 87 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogonad
otropin Beta
_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020
09:40:17ACV0PFEINFP6000  Data Entry:
Choriogonadotropin BetInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989581
Page 88 of 128
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US &
Canada)a_PX113
6.a Result:
Date Location User Value Reason
Sep-02-2020
09:40:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989582
Page 89 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
09:39:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
09:39:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
76558Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989583
Page 90 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
08:51:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
08:51:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
08:51:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
08:50:04
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
Sample ID: BP205BInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989584
Page 91 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Canada)
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
08:50:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP205BInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020
08:50:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP205CInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
08:50:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP205CInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
08:50:34
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sample ID: BP205DInitial Entry
090177e196ae3001\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-2021-5683-0989585
Page 92 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US &
Canada)
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
08:50:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP205DInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020
08:50:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWBCPInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020
08:50:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BNWBCPInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020
08:51:08ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3001\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-2021-5683-0989586
Page 93 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US &
Canada)Sample ID: BNWBCR
5.e Sample ID
Date Location User Value Reason
Sep-03-2020
08:51:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BNWBCRInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989587
Page 94 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
08:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
08:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
08:52:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
08:51:56
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
Sample ID: BPYG4BInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989588
Page 95 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Canada)
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
08:51:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BPYG4BInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989589
Page 96 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 09:20Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989590
Page 97 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION PE
RIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989591
Page 98 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Sep-02-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989592
Page 99 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
09:39:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989593
Page 100 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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-11-2020
03:19:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Saumitra Dubey Query 1: Closed Tracker
updated.
Oct-08-2020
12:53:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Covid Illness
visit has not
been completed
Oct-06-2020
15:24:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you
experienced any
of the
following?” for
the COVID-19
symptoms or
diagnosis on
01OCT2020.
But there is no
COVID Illness
visit reported in
the database.
Please clarify.
Sep-23-2020
16:48:54ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3001\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-2021-5683-0989594
Page 101 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989595
Page 102 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 98.2
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3001\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-2021-5683-0989596
Page 103 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020
16:49:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3001\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-2021-5683-0989597
Page 104 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989598
Page 105 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogonad
otropin Beta
_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020
16:49:22ACV0PFEINFP6000  Data Entry:
Choriogonadotropin BetaInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989599
Page 106 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00)
Eastern Time (US &
Canada)_PX113
6.a Result:
Date Location User Value Reason
Sep-23-2020
16:49:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989600
Page 107 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
16:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
16:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
08:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-24-2020
05:31:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989601
Page 108 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Sep-23-2020
16:49:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-23-2020
16:49:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
08:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP20T2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
08:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP20T2Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989602
Page 109 of 128
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 16:19Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989603
Page 110 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION PE
RIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989604
Page 111 of 128
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Sep-23-2020
16:49:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989605
Page 112 of 128
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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-21-2020
16:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989606
Page 113 of 128
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
16:06:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
16:06:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020
08:53:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-23-2020
02:05:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989607
Page 114 of 128
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-21-2020
16:06:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Oct-21-2020
16:06:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020
08:53:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR2XY
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-23-2020
08:53:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2XYLInitial Entry
5.b
Date Location User Value Reason
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989608
Page 115 of 128
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-23-2020
08:53:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR2XY
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020
08:53:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2XYMInitial Entry
5.c
Date Location User Value Reason
Oct-23-2020
08:54:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR2XY
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020
08:54:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2XYNInitial Entry
5.d
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989609
Page 116 of 128
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-23-2020
08:54:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS61M8Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-23-2020
08:54:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS61M8Initial Entry
5.e
Date Location User Value Reason
Oct-23-2020
08:54:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS61M9Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-23-2020
08:54:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS61M9Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989610
Page 117 of 128
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 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-22-2020
08:33:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
08:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
08:33:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989611
Page 118 of 128
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989612
Page 119 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
exposure during pregn
ancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021
02:49:10
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 2:
ClosedResponse satisfies query
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989613
Page 120 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US &
Canada)
Mar-05-2021
08:55:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Answere
dFollow up SAE form was
submitted
Mar-04-2021
03:08:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Reissued
:OpenedSAE RECON: Please confirm if
a follow up SAE form was
submitted to update onset date to
28Dec2020 in Safety database.
Mar-03-2021
13:02:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Answere
dOriginal value is correct
Feb-19-2021
01:38:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
OpenedSAE
RECON:AER#2021117359,onset
date was recorded as 09Jan2021
in SDB while 28Dec2020 in AE
CRF. As per V12 CRF CG
8.50.2.5, Date of onset is
determined by ultrasound results
or date of LMP. Please submit a
follow up AEM form to update
SDB onset date.
Feb-17-2021
08:49:39
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Giselle Castillo Query 1:
ClosedResponse satisfies query
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989614
Page 121 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US &
Canada)
Feb-11-2021
07:54:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
Answere
dTranscription Error
Feb-11-2021
07:54:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
Dec/28/2
020 00:0
0Transcription Error
Feb-10-2021
16:53:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query 1:
OpenedAs per V12 CRF CG 8.50.2.5,
Date of onset is determined by
ultrasound results or date of last
menstrual period (LMP). Per
report, LMP is 28Dec2020.
Please revise/update accordingly.
Thank you
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
Dec/15/2
020 00:0
0Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989615
Page 122 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US
& Canada)
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989616
Page 123 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time (US
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989617
Page 124 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Feb-23-2021
09:20:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Feb-22-2021
07:14:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dChanged data per query
Feb-21-2021
08:21:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Feb-19-2021
07:04:50
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedFor AE exposure during pregnancy:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989618
Page 125 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US &
Canada)the adverse event still ongoing?" is
marked "Yes".
Feb-19-2021
07:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
UNK
NOW
NChanged Information
Feb-19-2021
07:04:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per query
Feb-19-2021
01:42:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2021117359.Outcome
reported as
RECOVERING/RESOLVING in AE
CRF while UNKNOWN in SDB.As
per V12 CRF CG 8.50.2.5, the AE
outcome should be UNKNOWN in
Inform for ongoing pregnancies.
Please revise/update accordingly.
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989619
Page 126 of 128
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Feb-08-2021
11:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989620
Page 127 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-22-2020
08:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020
09:39:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Sep-02-2020
09:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-22-2020
08:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-02-2020
09:39:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-02-2020
09:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989621
Page 128 of 128
***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: 12321159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-28-2020
13:48:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3001\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989622