Document text
Page 1 of 172
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989985
Page 2 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/1/2020
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989986
Page 3 of 172
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Demography
1.Subject ID [12321293]
2.Birth Date: 1988
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989987
Page 4 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989988
Page 5 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989989
Page 6 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989990
Page 7 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989991
Page 8 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
2.Weight: [210.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [34.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989992
Page 9 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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: Oct/1/2020
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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989993
Page 10 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/1/2020
2.Randomization Number: [102837]
3.Randomization Group: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989994
Page 11 of 172
***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: 12321293 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/1/2020
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 [BR8K81]
5.bSample ID [BR8K82]
5.cSample ID [BR8K83]
5.dSample ID [BNTLCH]
5.eSample ID [BNTLCJ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989995
Page 12 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BR8K84]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989996
Page 13 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/1/2020 12:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989997
Page 14 of 172
***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: 12321293 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
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989998
Page 15 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989999
Page 16 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990000
Page 17 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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: Oct/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990001
Page 18 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BR2Y49]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990002
Page 19 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990003
Page 20 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990004
Page 21 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Nov/19/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
5.eSample ID [ ]
5 fSample ID [BR0HW1]
5.gSample ID [BR0HW2]
5.hSample ID [BR0HW3]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990005
Page 22 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990006
Page 23 of 172
***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: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990007
Page 24 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990008
Page 25 of 172
***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: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990009
Page 26 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990010
Page 27 of 172
***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: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990011
Page 28 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990012
Page 29 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990013
Page 30 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990014
Page 31 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990015
Page 32 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990016
Page 33 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990017
Page 34 of 172
***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: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990018
Page 35 of 172
***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: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990019
Page 36 of 172
***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: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990020
Page 37 of 172
***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: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990021
Page 38 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990022
Page 39 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Unplanned Assessments
1.Assessments
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990023
Page 40 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Exposure During Pregna
ncy Oct/22/2020 15:
19 YES Repeating
Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990024
Page 41 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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: Oct/22/2020 15:19
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990025
Page 42 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990026
Page 43 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990027
Page 44 of 172
***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: 12321293 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[ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990028
Page 45 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990029
Page 46 of 172
***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: 12321293 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: //
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990030
Page 47 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990031
Page 48 of 172
***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: 12321293 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?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990032
Page 49 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990033
Page 50 of 172
***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: 12321293 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?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990034
Page 51 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990035
Page 52 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990036
Page 53 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/22/2020 Comments
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990037
Page 54 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990038
Page 55 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990039
Page 56 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990040
Page 57 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990041
Page 58 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990042
Page 59 of 172
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990043
Page 60 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990044
Page 61 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990045
Page 62 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990046
Page 63 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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 [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990047
Page 64 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990048
Page 65 of 172
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990049
Page 66 of 172
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990050
Page 67 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990051
Page 68 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990052
Page 69 of 172
***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: 12321293 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: [ ]
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990053
Page 70 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/22/2020
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990054
Page 71 of 172
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990055
Page 72 of 172
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
Name Signature
MeaningDate Type Action
Approved Jan-20-2021 11:29:07 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990056
Page 73 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-02-2020 10:36:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990057
Page 74 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-02-2020 10:37:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990058
Page 75 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990059
Page 76 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990060
Page 77 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990061
Page 78 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990062
Page 79 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990063
Page 80 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990064
Page 81 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990065
Page 82 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
7Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990066
Page 83 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
8Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990067
Page 84 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
9Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990068
Page 85 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
10Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990069
Page 86 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
11Oct-27-2020 09:46:49 (UTC-05:00) Eastern Time
(US & Canada)subject did not receive V2 due to newfound
pregnancy
Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990070
Page 87 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormJan-18-2021 14:43:33 (UTC-05:00) Eastern Time
(US & Canada)
FormNov-11-2020 08:46:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990071
Page 88 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Jan-18-2021 14:43:33 (UTC-05:00) Eastern Time
(US & Canada)
1Nov-11-2020 08:46:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990072
Page 89 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Jan-18-2021 14:43:33 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-11-2020 08:46:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990073
Page 90 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Jan-18-2021 14:43:33 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-11-2020 08:46:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Nov-11-2020 08:36:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Nov-10-2020 17:57:27 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-10-2020 09:06:39 (UTC-05:00) Eastern Time
(US & Canada)Reason Incomplete
3Oct-30-2020 08:28:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990074
Page 91 of 172
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Jan-18-2021 14:43:33 (UTC-05:00) Eastern Time
(US & Canada)
4Nov-11-2020 08:46:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990075
Page 92 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Nov-16-2020 09:40:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
Not Applicable
6Nov-15-2020 14:23:09 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990076
Page 93 of 172
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-30-2020 09:30:17 (UTC-05:00) Eastern Time
(US & Canada)Subject will continue with study. End of Treatment
was entered in error.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990077
Page 94 of 172
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Nov-07-2020 12:09:58 (UTC-05:00) Eastern Time
(US & Canada)End of Treatment was due to EXPOSURE DURING
PREGNANCY
1Nov-02-2020 08:39:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990078
Page 95 of 172
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Nov-08-2020 13:50:53 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-02-2020 08:40:01 (UTC-05:00) Eastern Time
(US & Canada)Subject decided to stay in study. EOT was entered in
error
Not Done
3Oct-30-2020 10:05:35 (UTC-05:00) Eastern Time
(US & Canada)Subject decided to stay in study. EOT was entered in
error
Not Applicable
090177e196ae2fff\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-2021-5683-0990079
Page 96 of 172
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Nov-02-2020 08:40:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Nov-02-2020 08:38:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990080
Page 97 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormNov-16-2020 09:41:32 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
Not Applicable
FormNov-11-2020 11:11:35 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990081
Page 98 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Nov-16-2020 09:41:32 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990082
Page 99 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Nov-16-2020 09:41:32 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990083
Page 100 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Nov-16-2020 09:41:32 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990084
Page 101 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Nov-16-2020 09:41:32 (UTC-05:00) Eastern Time
(US & Canada)Disposition-F/U is not completed yet
Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990085
Page 102 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormDec-11-2020 11:03:25 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-11-2020 08:07:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990086
Page 103 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Dec-11-2020 08:07:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Nov-06-2020 11:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990087
Page 104 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Dec-11-2020 08:07:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Nov-06-2020 11:14:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990088
Page 105 of 172
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
Name Signature
MeaningDate Type Action
Approved Jan-20-2021 11:29:07 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-11-2020 08:07:16 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-24-2020 08:40:54 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-23-2020 07:59:42 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley Approved Nov-16-2020 11:56:47 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990089
Page 106 of 172
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Affidavit:
By my dated signature below, I, JeffreyKingsley, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-15-2020 14:22:51 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley Approved Nov-12-2020 12:30:20 (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.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990090
Page 107 of 172
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-02-2020 10:36:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-02-2020 10:36:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990091
Page 108 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-02-2020 10:36:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/1/2020Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990092
Page 109 of 172
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020 10:35:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12321293Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-02-2020 10:35:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1988Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-02-2020 10:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-02-2020 10:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-02-2020 10:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERICA
NInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990093
Page 110 of 172
***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: 12321293 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-02-2020 10:36:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990094
Page 111 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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-02-2020 10:37:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 10:37:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 10:37:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990095
Page 112 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
210.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.9Initial Entry
7.a
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990096
Page 113 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 10:38:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990097
Page 114 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990098
Page 115 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-02-2020 10:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990099
Page 116 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-02-2020 10:38:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-02-2020 10:38:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
102837Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990100
Page 117 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 10:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 10:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 10:39:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 10:39:12
(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-02-2020 10:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 10:39:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8K81Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990101
Page 118 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-02-2020 10:39:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8K81Initial Entry
5.b
Date Location User Value Reason
Oct-02-2020 10:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8K82Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 10:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8K82Initial Entry
5.c
Date Location User Value Reason
Oct-02-2020 10:39:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8K83Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 10:39:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8K83Initial Entry
5.d
Date Location User Value Reason
Oct-02-2020 10:40:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTLCHInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020 10:40:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNTLCHInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990102
Page 119 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e
Date Location User Value Reason
Oct-02-2020 10:40:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTLCJInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-02-2020 10:40:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNTLCJInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990103
Page 120 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 10:40:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 10:40:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 10:40:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 10:40:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8K84Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 10:40:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8K84Initial Entry
090177e196ae2fff\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-2021-5683-0990104
Page 121 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020 12:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fff\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-2021-5683-0990105
Page 122 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-02-2020 10:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990106
Page 123 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-02-2020 10:41:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990107
Page 124 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-02-2020
14:48:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_SV001_02
Nov-02-2020
08:37:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per query
Nov-02-2020
02:58:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5230805;The Date of
Visit at Visit V2_VAX2_L is
the same as the other Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Oct-27-2020
09:44:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/2
2/202
0Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990108
Page 125 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2.a
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-27-2020 09:44:40
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990109
Page 126 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990110
Page 127 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: POSITIVEInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990111
Page 128 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-27-2020 09:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-03-2020
03:17:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Clo
sedResponse satisfies
query
Nov-02-2020
08:41:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: An
sweredChanged data per
query
Nov-02-2020
00:04:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Op
enedDMW5235567;There
is a pregnancy test
with a positive result,
but there is no
disposition eCRF
with a 'Status' of
PREGNANCY with a
disposition date on or
after the pregnancy
test date. Please
review and update as
appropriate.
Oct-28-2020
04:39:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clo
sedClosed per SITE
response, added to
PD tracker for
Clinical Review
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990112
Page 129 of 172
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-27-2020
09:58:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredStudy procedures for
V2 were conducted
minus vaccination 2
administration.
Oct-27-2020
09:44:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedLab result is
“Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
Oct-27-2020
09:44:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990113
Page 130 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 10:00:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 10:00:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 10:00:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 10:00:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR2Y49Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 10:00:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR2Y49Initial Entry
090177e196ae2fff\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-2021-5683-0990114
Page 131 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-29-2020
07:27:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edResponse satisfies query
Oct-28-2020
16:25:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDosing was not performed due
to subject having a positive
pregnancy test at V2
Oct-28-2020
15:37:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW5207836;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990115
Page 132 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
appropriate.
Oct-27-2020
09:46:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990116
Page 133 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-27-2020 09:46:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990117
Page 134 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-19-2021
08:18:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
5: Clo
sedClose Auto Query
Jan-19-2021
05:01:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Ope
nedErroneous Visit is marked, but
date of visit is entered. Please
either untick the erroneous
visit button if visit occurred, or
mark any forms containing
data within this visit as Not
Done/Not Applicable at the
form level.
Jan-18-2021
14:44:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
5: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
either untick the erroneous
visit button if visit occurred, or
mark any forms containing
data within this visit as Not
Done/Not Applicable at the
form level.
Jan-18-2021
14:44:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Nov/1
9/2020Transcription Error
Nov-26-2020
13:00:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Del
etedNo other assessments are
performed at this visit.
Nov-23-2020
07:59:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
check whether other
assessments are performed at
this visit.
090177e196ae2fff\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-2021-5683-0990118
Page 135 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-23-2020
07:59:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/19
/2020Transcription Error
Nov-04-2020
06:49:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Del
etedQuery is invalid or does not
apply
Nov-03-2020
00:17:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Nov-02-2020
08:37:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredV3 has not been completed.
Data entered in error
Nov-02-2020
08:37:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
check whether other
assessments are performed at
this visit.
Nov-02-2020
02:58:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Ope
nedDMW5230806;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit V2_VAX2_L.
Please review for duplication
and update as appropriate.
Oct-30-2020
08:27:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Oct-30-2020
08:27:01
(UTC-05:00)ACV0PFEINFP6000 Data
Entry
:Transcription Error
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990119
Page 136 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Eastern Time
(US &
Canada)Oct/22
/2020
Oct-30-2020
08:25:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ope
nedDate of Visit is after the Date
of Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Oct-30-2020
08:25:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/29
/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-19-2021 08:18:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-02-2020 08:37:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2fff\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-2021-5683-0990120
Page 137 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021 14:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Jan-18-2021 14:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Nov-11-2020 08:46:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-30-2020 08:28:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 08:26:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021 14:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Jan-18-2021 14:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Nov-11-2020 08:46:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-30-2020 08:28:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 08:26:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990121
Page 138 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Jan-18-2021 14:45:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-18-2021 14:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-18-2021 14:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
Jan-18-2021 14:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-11-2020 16:52:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 08:47:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-11-2020 08:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 04:01:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM2: As this visit is
marked as erroneous
visit, please consider
adding a form level
comment "Not
applicable" by
removing data
recorded on initiated
CRFs under this visit.
Refer to section
4.11.3/4.10 of
completion
guidelines. Thank
you
Nov-10-2020 18:00:00
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Answered Visit is erroneous.
Data and comment
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990122
Page 139 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada) have been deleted
Nov-10-2020 17:57:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 13:58:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: If visit is
erroneous, refer to
CRF CR section
8.4.2. Erroneous Visit
to complete this visit.
Please review and
update as appropriate.
Thank you.
Nov-10-2020 09:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-10-2020 01:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened FORM level 'Not
Done' comment must
be applied, not Item
level comment.
Please add new form
level comment with
‘Reason Incomplete’
selection 'Not Done'.
Please contact CRA if
needed. Thank you
Nov-09-2020 08:29:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-09-2020 06:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Form level
'Not Done' comment
not applied as
required. Please add
new form level
comment with
‘Reason Incomplete’
selection 'Not Done'.
Refer to section 4.10
of completion
guidelines or contact
CRA is needed.
Thanks
Nov-08-2020 14:00:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered NOT DONE has been
entered
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0990123
Page 140 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-08-2020 05:49:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Kindly provide the
Form level comment
"NOT DONE".
Thank you.
Nov-07-2020 12:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Comment added NOT
DONE
Nov-07-2020 02:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Please add form level
comment of NOT
DONE.
Oct-30-2020 08:28:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-30-2020 08:28:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:26:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-18-2021 14:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-11-2020 08:46:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-10-2020 17:58:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-10-2020 09:07:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IncompleteTranscription Error
Nov-09-2020 08:29:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Visit was entered in errorTranscription Error
Nov-07-2020 12:13:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990124
Page 141 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
5.a
Date Location User Value Reason
Oct-30-2020 08:29:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
(DELETED)
Oct-30-2020 08:27:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Oct-30-2020 08:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HKDInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 08:29:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Oct-30-2020 08:27:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HKDInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 08:29:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
(DELETED)
Oct-30-2020 08:27:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Oct-30-2020 08:25:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HKFInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990125
Page 142 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 08:29:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Oct-30-2020 08:27:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:25:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HKFInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020 08:29:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
(DELETED)
Oct-30-2020 08:27:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Oct-30-2020 08:25:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HKGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 08:29:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Oct-30-2020 08:27:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:25:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HKGInitial Entry
5.d
Date Location User Value Reason
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990126
Page 143 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-30-2020 08:29:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
(DELETED)
Oct-30-2020 08:27:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Oct-30-2020 08:25:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS61WJInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 08:29:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Oct-30-2020 08:27:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:25:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS61WJInitial Entry
5.e
Date Location User Value Reason
Oct-30-2020 08:29:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
(DELETED)
Oct-30-2020 08:28:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Oct-30-2020 08:26:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS61WKInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990127
Page 144 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e Sample ID
Date Location User Value Reason
Oct-30-2020 08:29:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Oct-30-2020 08:28:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 08:26:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS61WKInitial Entry
5.f
Date Location User Value Reason
Jan-18-2021 14:45:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HW1Initial Entry
5.f Sample ID
Date Location User Value Reason
Jan-18-2021 14:45:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HW1Initial Entry
5.g
Date Location User Value Reason
Jan-18-2021 14:46:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HW2Initial Entry
5.g Sample ID
Date Location User Value Reason
Jan-18-2021 14:46:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HW2Initial Entry
5.h
Date Location User Value Reason
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990128
Page 145 of 172
***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, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Jan-18-2021 14:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HW3Initial Entry
5.h Sample ID
Date Location User Value Reason
Jan-18-2021 14:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HW3Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990129
Page 146 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990130
Page 147 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 09:49:42
(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
Nov-09-2020 05:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-07-2020 12:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AEM form has been
submitted
Nov-06-2020 07:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 1: Event
term still reported as
pregnancy in SDB.
please confirm if
follow up AEM form
was submitted to
update term to
exposure during
pregnancy
Nov-06-2020 06:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate SAE Recon: pending
SDB update
Nov-05-2020 17:36:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AEM form to be
submitted with term
"Exposure During
Pregnancy".
Nov-05-2020 06:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2020429479, the
term in Safety was
reported as
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990131
Page 148 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
PREGNANCY. Per
latest EDP guideline,
the term should be
reported as
EXPOSURE DURING
PREGNANCY. Please
submit a follow up
AEM form to update
term in Safety
database.
Oct-30-2020 15:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Closed Response satisfies
query
Oct-29-2020 15:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer query
Oct-29-2020 15:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure During PregnancyAnswer query
Oct-29-2020 15:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Opened GPD Clin: Please
change the event term
to "exposure during
pregnancy."
Oct-27-2020 09:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020 15:19Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 07:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-28-2020 09:22:03 ACV0PFEINFP6000 auto query Query 1: Opened 'Disposition
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990132
Page 149 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00) Eastern Time
(US & Canada)(autoquery) Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 09:40:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-15-2020 16:55:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-15-2020 14:22:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-15-2020 14:22:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-15-2020 01:39:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Toxicity grade is not
expected for
pregnancy related
adverse events, hence
please remove the
toxicity and add item
level comment as
NOT APPLICABLE.
Oct-27-2020 09:49:52
(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
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990133
Page 150 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-13-2020 05:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Closed Response satisfies query
Nov-12-2020 09:48:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6: Answered Transcription Error
Nov-12-2020 09:48:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Nov-12-2020 06:08:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 7: Deleted Query can be addressed
internally
Nov-12-2020 06:07:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 7: Candidate For AE Exposure During
Pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Nov-12-2020 06:07:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Opened SAE RECON:
AER#2020408343,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is met if there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Nov-10-2020 09:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Closed Close Auto Query
Nov-10-2020 09:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?Transcription Error
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990134
Page 151 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YES
Nov-10-2020 03:31:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Opened For AE Exposure During
Pregnancy: Response to "Is the
adverse event serious?" is 'No'
but "Serious Adverse Event
Number" is present.
Nov-10-2020 02:29:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies query
Nov-09-2020 10:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE Exposure During
Pregnancy: Response to "Is the
adverse event serious?" is 'No'
but "Serious Adverse Event
Number" is present.
Nov-09-2020 10:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Transcription Error
Nov-09-2020 10:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Nov-08-2020 19:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened SAE RECON:
AER#2020408343,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is metthere is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990135
Page 152 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-06-2020 07:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Nov-05-2020 06:07:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed reported under AER
2020429479
Nov-05-2020 05:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidat
eSAE RECON: Pending SDB
update
Nov-04-2020 10:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AEM form has been resent.
Nov-04-2020 05:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 2: Per PSSR
confirmation via email 'The
DSU (Argentina) does not have
any record of the Pregnancy
report for subject#1231293.
Please submit an AEM form to
report the Pregnancy event to
Pfizer Safety
Nov-02-2020 12:03:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Unable to answer the question
"Serious Adverse Event
Number" as it states for Pfizer
Use Only
Nov-02-2020 10:09:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: For AE Exposure During
Pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Oct-30-2020 07:12:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidat
eSAE RECON: pending
confirmation from pssr
Oct-29-2020 15:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Exposure During
Pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Oct-29-2020 08:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Pregnancy even was reported to
Pfizer safety via Fax.
Oct-29-2020 05:28:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 1: Event missing
in safety database listing. Please
confirm if the pregnancy event
was reported to Pfizer safety.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990136
Page 153 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-28-2020 09:48:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Pregnancy is considered to be
SAE.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990137
Page 154 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
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
Oct-28-2020 09:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Oct-28-2020 09:37:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
Pregnancy(Onset
date:22Oct2020) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-27-2020 09:51:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NOTranscription Error
090177e196ae2fff\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-2021-5683-0990138
Page 155 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
YES
Oct-27-2020 09:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-27-2020 09:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
YES
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s eventInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990139
Page 156 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-08-2020 16:58:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-07-2020 12:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered EOT page has been
updated
Nov-06-2020 18:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: On the
EOT tab: The Not
Done comments need
to be removed from
the form (via speech
bubble) prior to the
data fields releasing
for new data to be
entered. The page
isn't frozen
Nov-06-2020 17:54:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Unable to change data
on the EOT tab.
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990140
Page 157 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-06-2020 15:52:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Field
indicates Drug
Withdrawn due to
pregnancy. Please
update the EOT tab to
indicate subject has
discontinued
treatment due to this
AE
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 02:04:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-28-2020 09:51:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto Query
Oct-28-2020 09:51:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGTranscription Error
Oct-28-2020 07:53:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM: Kindly verify if
AE ‘Pregnancy’ is
ongoing if Yes then
update response to
‘"What was the
outcome of this
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990141
Page 158 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
adverse event?" on
this page. Else update
response to ‘Is the
adverse event still
ongoing?’ as
appropriate.
Oct-27-2020 09:57:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Oct-27-2020 09:51:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but End
Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Oct-27-2020 09:51:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNTranscription Error
Oct-27-2020 09:50:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-27-2020 09:50:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGTranscription Error
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 3 but End
Date/Time is missing.
Oct-27-2020 09:49:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 09:59:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 4: Closed Response satisfies
query
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990142
Page 159 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-10-2020 09:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Transcription Error
Nov-10-2020 09:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Nov-10-2020 04:30:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 4: Reissued:Opened CLINQUERY: Since
V3 is scheduled to fall
after the data
snapshot, please
review if status
should be marked as
continuing with study
at the time of the snap
Nov-08-2020 14:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Will update if subject
comes in for V3
Nov-07-2020 14:16:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 4: Opened CLINQUERY: Please
note, this question
(and the FUP tab)
correspond to the
subject not continuing
within safety follow
up (end of study). If
follow up will
continue (despite
treatment withdrawn),
please update this
field to 'no', and clear
the FUP tab
Nov-02-2020 10:11:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Deleted DISPOSITION -
TREATMENT is
updated.
Oct-30-2020 15:55:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 2: Closed Response satisfies
query
Oct-30-2020 09:29:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990143
Page 160 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-29-2020 15:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered EOT CRF has been
completed
Oct-29-2020 15:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 2: Opened GPD Clin: Please
complete the EOT
CRF.
Oct-29-2020 07:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 09:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-28-2020 06:38:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-27-2020 09:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-27-2020 09:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990144
Page 161 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-12-2020 06:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: non serious in SDB
Nov-05-2020 06:09:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020429479Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990145
Page 162 of 172
***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: 12321293 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
Nov-08-2020 05:53:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-07-2020 12:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Nov-07-2020 12:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
Nov-07-2020 12:09:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-07-2020 02:04:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 2: Opened In case subject
discontinued the
treatment, then please
remove comment and
enter the details.
Nov-03-2020 07:34:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-02-2020 08:39:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-02-2020 08:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-02-2020 08:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-02-2020 07:09:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Per comment,
please remove data
from this form and
add form level
comment "Not
applicable". Thank
you.
Oct-29-2020 15:54:23 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990146
Page 163 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00) Eastern Time
(US & Canada)Oct/22/2020
2. Phase of Disposition:
Date Location User Value Reason
Nov-07-2020 12:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Nov-02-2020 08:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-29-2020 15:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-08-2020 16:57:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-08-2020 13:51:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-08-2020 13:51:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYTranscription Error
Nov-08-2020 13:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-07-2020 16:05:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: The
'Not Done' has been
entered via a
comment in the field
(speech bubble). This
needs to be removed
and field saved first,
before the new data
can be selected
Nov-07-2020 15:42:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Unable to change Not
Done to
PREGNANCY
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990147
Page 164 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-07-2020 14:18:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Per V2
and AE log,
vaccination 2 was not
given due to
Pregnancy. Please
then update this EOT
tab to report status
PREGNANCY from
the selection as the
reason for treatment
discontinuation
Nov-02-2020 08:40:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-30-2020 10:05:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-30-2020 09:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-29-2020 15:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-02-2020 08:40:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-02-2020 08:38:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990148
Page 165 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 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
Nov-16-2020 09:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 11:10:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: New Information
Oct-28-2020 09:22:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020 09:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 11:10:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: New Information
Oct-28-2020 09:22:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-16-2020 09:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 11:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Nov-11-2020 11:05:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Nov-11-2020 11:05:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: New Information
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990149
Page 166 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-11-2020 10:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Opened CLINQUERY:
Thanks for
confirming subject
will continue with the
study - please remove
then all data from this
page
Nov-10-2020 23:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-10-2020 18:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Should be marked as
continuing
Nov-10-2020 18:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Status to be marked as
continuing with study.
Nov-10-2020 09:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Nov-10-2020 09:41:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY: Since
V3 is scheduled to fall
after the data
snapshot, please
review if status
should be marked as
continuing with study
at the time of the
snap. Else, update
status to be
PREGNANCY to
match the event
Nov-10-2020 04:30:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Candidate CLINQUERY: Since
V3 is scheduled to fall
after the data
snapshot, please
review if status
should be marked as
continuing with study
at the time of the
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990150
Page 167 of 172
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
snap. Else, update
status to be
PREGNANCY to
match the event
Oct-28-2020 09:22:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-28-2020 09:22:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-28-2020 09:22:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-16-2020 09:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-30-2020 15:56:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Closed Response satisfies
query
Oct-30-2020 09:26:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject did not refuse
follow up
Oct-29-2020 15:42:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Opened GPD Clin: Please
confirm if the subject
refused safety
follow-up.
Oct-28-2020 09:22:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-28-2020 09:22:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
pregnancyInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990151
Page 168 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-14-2020 02:58:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Closed as data
updated.
Dec-11-2020 11:04:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered Not applicable entered
at form level
comment.
Dec-11-2020 03:13:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 3: Opened The comment "Not
Applicable" is applied
at item level currently.
Please remove the
comment and enter at
form level. Thank
you.
Nov-09-2020 04:40:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Data updated
Nov-07-2020 10:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Site has not updated
form level comment.
Please review and
action.
Nov-06-2020 11:15:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated
Nov-06-2020 11:14:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-06-2020 03:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Kindly consider
to update this form if
require else mark as
Not applicable by
selecting form level
comment. Thank you.
Nov-05-2020 05:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-04-2020 10:30:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0990152
Page 169 of 172
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-04-2020 10:30:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-04-2020 10:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened IVRS RQ1 : Per
response 'Treatment
Unblinded Form was
not found in subj
source' please confirm
if treatment was
Unblinded on
22Oct2020. Thank
you.
Nov-04-2020 08:29:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Treatment Unblinded
Form was not found
in subj source
Nov-03-2020 08:30:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Katherine Puig Query 1: Opened IVRS Reconciliation:
BLIND BROKEN? in
IMPALA is NO but
TREATMENT
UNBLINDED form
has been completed in
InForm. Please review
and update as
appropriate. Else,
clarify. Thank you.
Nov-02-2020 08:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Nov-06-2020 11:14:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 10:30:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-02-2020 08:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OTHER
If other, specify:
PregnancyInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0990153
Page 170 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020 11:05:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDNew Information
Nov-08-2020 13:51:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-30-2020 09:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-29-2020 15:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-28-2020 09:22:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-02-2020 10:38:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-02-2020 10:37:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 11:10:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020New Information
Nov-11-2020 11:05:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020New Information
Nov-08-2020 13:51:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Transcription Error
Nov-07-2020 12:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990154
Page 171 of 172
***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: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-02-2020 08:39:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Transcription Error
Oct-30-2020 09:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Transcription Error
Oct-29-2020 15:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-28-2020 09:22:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-02-2020 10:38:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Oct-02-2020 10:37:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990155
Page 172 of 172
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321293 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-12-2020 11:53:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fff\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990156