Document text
Page 1 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989784
Page 2 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989785
Page 3 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Demography
1.Subject ID [12321213]
2.Birth Date: 1996
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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989786
Page 4 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989787
Page 5 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989788
Page 6 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989789
Page 7 of 201
***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: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989790
Page 8 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [238.0]
3.Unit: LB
4.Height: [62.0]
5.Unit: in
6.Body Mass Index: [43.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989791
Page 9 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989792
Page 10 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [84986]
3.Randomization Group: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989793
Page 11 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP20BL]
5.bSample ID [BP20BM]
5.cSample ID [BP20BN]
5.dSample ID [BNW9SJ]
5.eSample ID [BNW9SK]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989794
Page 12 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP20CN]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989795
Page 13 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 11:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989796
Page 14 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989797
Page 15 of 201
***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: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989798
Page 16 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989799
Page 17 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989800
Page 18 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989801
Page 19 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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: POSITIVE
Not Done:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989802
Page 20 of 201
***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: 12321213 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 [BR8KG2]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989803
Page 21 of 201
***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: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989804
Page 22 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989805
Page 23 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989806
Page 24 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location:
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Applicable Comments
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989807
Page 25 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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/30/2020
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 [BR0HL8]
5.bSample ID [BR0HL9]
5.cSample ID [BR0HLB]
5.dSample ID [BS61XM]
5.eSample ID [BS61XN]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989808
Page 26 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989809
Page 27 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989810
Page 28 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989811
Page 29 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989812
Page 30 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989813
Page 31 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989814
Page 32 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989815
Page 33 of 201
***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: 12321213 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: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989816
Page 34 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989817
Page 35 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989818
Page 36 of 201
***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: 12321213 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?
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989819
Page 37 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989820
Page 38 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989821
Page 39 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989822
Page 40 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989823
Page 41 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Unplanned Assessments
1.Assessments
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989824
Page 42 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989825
Page 43 of 201
***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: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989826
Page 44 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989827
Page 45 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989828
Page 46 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Exposure during pregn
ancy Oct/1/2020 UNK:U
NK YES Repeating
Pages
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989829
Page 47 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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/1/2020 UNK:UNK
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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989830
Page 48 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
13.What was the outcome of this adverse
event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989831
Page 49 of 201
***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: 12321213 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 Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989832
Page 50 of 201
***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: 12321213 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[ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989833
Page 51 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989834
Page 52 of 201
***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: 12321213 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: //
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989835
Page 53 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989836
Page 54 of 201
***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: 12321213 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?
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989837
Page 55 of 201
***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: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989838
Page 56 of 201
***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: 12321213 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?
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989839
Page 57 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989840
Page 58 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989841
Page 59 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989842
Page 60 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989843
Page 61 of 201
***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: 12321213 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:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989844
Page 62 of 201
***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: 12321213 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?
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989845
Page 63 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989846
Page 64 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989847
Page 65 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989848
Page 66 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989849
Page 67 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989850
Page 68 of 201
***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: 12321213 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 [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989851
Page 69 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989852
Page 70 of 201
***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: 12321213 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?
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989853
Page 71 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989854
Page 72 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989855
Page 73 of 201
***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: 12321213 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: [ ]
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989856
Page 74 of 201
***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: 12321213 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/30/2020
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989857
Page 75 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 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
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989858
Page 76 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989859
Page 77 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-09-2020 12:30:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989860
Page 78 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormSep-09-2020 12:31:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989861
Page 79 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Oct-23-2020 09:13:32 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
4Oct-12-2020 09:49:10 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989862
Page 80 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormOct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989863
Page 81 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989864
Page 82 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989865
Page 83 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989866
Page 84 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989867
Page 85 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989868
Page 86 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989869
Page 87 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
7Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989870
Page 88 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
8Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989871
Page 89 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
9Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989872
Page 90 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
10Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989873
Page 91 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
11Oct-12-2020 09:49:34 (UTC-05:00) Eastern Time
(US & Canada)Did not give Pt V2 due to unknown pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989874
Page 92 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Feb-10-2021 10:24:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989875
Page 93 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.aFeb-15-2021 10:04:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989876
Page 94 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.bFeb-15-2021 10:05:00 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989877
Page 95 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.cFeb-15-2021 10:05:11 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989878
Page 96 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.dFeb-15-2021 10:05:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989879
Page 97 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.eFeb-15-2021 10:05:33 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989880
Page 98 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.fFeb-15-2021 10:05:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989881
Page 99 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.gFeb-15-2021 10:05:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989882
Page 100 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2.hFeb-15-2021 10:06:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989883
Page 101 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Feb-15-2021 10:06:31 (UTC-05:00) Eastern Time
(US & Canada)Pt did not get injection due to pregnancy
Not Applicable
4Oct-30-2020 10:15:22 (UTC-05:00) Eastern Time
(US & Canada)Pt did not get injection due to pregnancy
Not Done
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989884
Page 102 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5.aFeb-15-2021 10:07:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989885
Page 103 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5.bFeb-15-2021 10:07:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989886
Page 104 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
5.cFeb-15-2021 10:08:08 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989887
Page 105 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormNov-16-2020 09:39:46 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
Not Applicable
FormOct-26-2020 09:24:48 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
FormOct-23-2020 16:29:37 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
FormOct-16-2020 09:24:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormOct-16-2020 09:24:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormOct-15-2020 09:40:57 (UTC-05:00) Eastern Time
(US & Canada)There was no Disposition Follow Up, entered in
error. Cannot removed page or date
090177e196ae2ffe\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-2021-5683-0989888
Page 106 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Nov-16-2020 09:39:46 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
Not Applicable
1Oct-26-2020 09:24:48 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
1Oct-16-2020 09:24:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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-2021-5683-0989889
Page 107 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Nov-16-2020 09:39:46 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
Not Applicable
2Oct-26-2020 09:24:48 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
2Oct-16-2020 09:24:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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-2021-5683-0989890
Page 108 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
3Nov-16-2020 09:39:46 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
Not Applicable
3Oct-26-2020 09:24:48 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
3Oct-16-2020 09:24:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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-2021-5683-0989891
Page 109 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
4Nov-16-2020 09:39:46 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
Not Applicable
4Oct-26-2020 09:24:48 (UTC-05:00) Eastern Time
(US & Canada)FUP should be changed to 01Oct2020 (Date) and
reason for discontinuation should be AE.
4Oct-16-2020 09:24:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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-2021-5683-0989892
Page 110 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
6Nov-16-2020 09:39:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
Not Applicable
6Nov-15-2020 14:19:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989893
Page 111 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
FormDec-16-2020 08:21:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-16-2020 08:21:23 (UTC-05:00) Eastern Time
(US & Canada)
FormDec-16-2020 08:20:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-16-2020 08:20:31 (UTC-05:00) Eastern Time
(US & Canada)
FormDec-14-2020 12:25:25 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-14-2020 12:24:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-11-2020 10:55:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-11-2020 08:11:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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)
FDA-CBER-2021-5683-0989894
Page 112 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
1Dec-16-2020 08:21:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Dec-16-2020 08:21:23 (UTC-05:00) Eastern Time
(US & Canada)
1Dec-16-2020 08:20:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Dec-16-2020 08:20:31 (UTC-05:00) Eastern Time
(US & Canada)
1Dec-14-2020 12:25:25 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Dec-14-2020 12:24:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Dec-11-2020 08:11:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Nov-06-2020 11:15:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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)
FDA-CBER-2021-5683-0989895
Page 113 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
ItemDate User Comment
2Dec-16-2020 08:21:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Dec-16-2020 08:21:23 (UTC-05:00) Eastern Time
(US & Canada)
2Dec-16-2020 08:20:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Dec-16-2020 08:20:31 (UTC-05:00) Eastern Time
(US & Canada)
2Dec-14-2020 12:25:25 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Dec-14-2020 12:24:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Dec-11-2020 08:11:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Nov-06-2020 11:15:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2ffe\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)
FDA-CBER-2021-5683-0989896
Page 114 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-10-2021 10:24:10 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-20-2021 10:52:21 (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 08:11:54 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Kingsley Approved Nov-16-2020 11:54:22 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyKingsley, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-15-2020 14:17:14 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989897
Page 115 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Affidavit:
N/A
Jeffrey Kingsley Approved Nov-11-2020 09:11:13 (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.
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989898
Page 116 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020 12:29:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 12:29:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989899
Page 117 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020 12:29:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/9/2020Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989900
Page 118 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020 12:29:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12321213Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020 12:29:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1996Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020 12:30:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-09-2020 12:30:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020 12:30:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERICA
NInitial Entry
090177e196ae2ffe\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-2021-5683-0989901
Page 119 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 12:30:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989902
Page 120 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020 12:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020 12:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 12:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989903
Page 121 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
238.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
62.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
43.5Initial Entry
7.a
090177e196ae2ffe\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-2021-5683-0989904
Page 122 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 12:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ffe\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-2021-5683-0989905
Page 123 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989906
Page 124 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 12:32:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989907
Page 125 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020 12:32:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020 12:32:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
84986Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989908
Page 126 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 08:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 08:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 08:16:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP20BLInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:16:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP20BLInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 08:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP20BMInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989909
Page 127 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 08:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP20BMInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020 08:16:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP20BNInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 08:16:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP20BNInitial Entry
5.d
Date Location User Value Reason
Sep-10-2020 08:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW9SJInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 08:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNW9SJInitial Entry
5.e
Date Location User Value Reason
Sep-10-2020 08:16:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW9SKInitial Entry
090177e196ae2ffe\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-2021-5683-0989910
Page 128 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.e Sample ID
Date Location User Value Reason
Sep-10-2020 08:16:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNW9SKInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989911
Page 129 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 08:17:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 08:17:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:17:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 08:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP20CNInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP20CNInitial Entry
090177e196ae2ffe\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-2021-5683-0989912
Page 130 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 11:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2ffe\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-2021-5683-0989913
Page 131 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020 12:32:54
(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
Sep-09-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989914
Page 132 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-29-2020 03:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-28-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-28-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTTranscription Error
Sep-28-2020 10:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Per Trial
Max, Subject is the
subset of
'Reactogenicity Diary
collection'. Please
review and consider
to update response for
'Reactogenicity diary
collection' as 'Yes',
else clarify in query
response. Thanks
Sep-09-2020 12:33:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989915
Page 133 of 201
***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: 12321213 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-13-2020 04:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Oct-12-2020 09:49:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Oct-05-2020 10:43:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete
‘Vaccination form,
Vaccination
Symptoms Diary -
Symptom Resolved
Date form' at this
visit. Thank you.
Oct-05-2020 10:21:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989916
Page 134 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2ffe\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-2021-5683-0989917
Page 135 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989918
Page 136 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.d
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989919
Page 137 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.e Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-12-2020 09:48:21 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ffe\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) (6)
FDA-CBER-2021-5683-0989920
Page 138 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(UTC-05:00) Eastern Time
(US & Canada)Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.g Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989921
Page 139 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.h Symptom:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-23-2020 14:07:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-23-2020 09:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-23-2020 09:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
Oct-23-2020 09:13:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-22-2020 20:42:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Steven Finegan
ProdQuery 1: Opened V1 vaccination body
side is reported as
"RIGHT" while V2
Injection site body
side is reported as
"Not Done". Please
review and update as
appropriate.
090177e196ae2ffe\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-2021-5683-0989922
Page 140 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-12-2020 09:49:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989923
Page 141 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - 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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020 09:48:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989924
Page 142 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date:
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-05-2020 10:25:09
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ffe\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-2021-5683-0989925
Page 143 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989926
Page 144 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-05-2020 10:25:30
(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-05-2020 10:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-05-2020 10:25:30
(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-05-2020 10:25:30
(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-05-2020 10:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-05-2020 10:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989927
Page 145 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Result:: POSITIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-05-2020 10:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-05-2020 10:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020
04:40:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
osedClosed as data
updated under DISP
visit.
Oct-20-2020
09:14:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: An
sweredupdated
Oct-20-2020
02:49:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Open
edThanks for the
response, form has
been unfreeze, please
update as per below
query
Oct-19-2020
11:26:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: An
sweredPlease unlock
disposition eCRF so
status can be
corrected.
Oct-19-2020
02:23:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Op
enedDMW5057765;There
is a pregnancy test
with a positive result,
but there is no
disposition eCRF
090177e196ae2ffe\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-2021-5683-0989928
Page 146 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
with a 'Status' of
PREGNANCY with a
disposition date on or
after the pregnancy
test date. Please
review and update as
appropriate.
Oct-09-2020
02:34:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedClosed per SITE
response, added to
PD tracker
Oct-08-2020
16:45:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredSubject was
vaccinated at V1
when subject was not
pregnant, subject was
not given IP at V2
due to positive
pregnancy test.
Oct-05-2020
10:25:30
(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-05-2020
10:25:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
POSITIVEInitial Entry
090177e196ae2ffe\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-2021-5683-0989929
Page 147 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 10:27:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 10:27:45
(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-05-2020 10:27:45
(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-05-2020 10:27:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8KG2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 10:27:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8KG2Initial Entry
090177e196ae2ffe\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-2021-5683-0989930
Page 148 of 201
***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: 12321213 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-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-16-2020
06:35:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-15-2020
09:56:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredthe Disposition-Follow Up
was entered in error
Oct-13-2020
16:08:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4962477;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
090177e196ae2ffe\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-2021-5683-0989931
Page 149 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
appropriate.
Oct-12-2020
09:49:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2ffe\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-2021-5683-0989932
Page 150 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-12-2020 09:49:34
(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-12-2020 09:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989933
Page 151 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020
05:31:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Close
dResponse satisfies query
Nov-01-2020
20:15:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: Close
dAuto closed by Validation
Check: VC_SV001_04_AN
Nov-01-2020
13:18:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answ
eredAnswer Auto Query
Nov-01-2020
13:17:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answ
eredChanged data per query
Nov-01-2020
04:14:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDM: Form is unfrozen
please update the
Follow-Up Disposition
form data as per below
query.
Nov-01-2020
04:13:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Reissu
ed:Ope
nedDM: Form is unfrozen
please update the EOT data
as per below query.
Oct-30-2020
18:15:44
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 2
: Answ
eredSubject did not receive
vaccination at Visit 2 due to
AE. Visit 3 was performed
on 30Oct2020. EOT should
090177e196ae2ffe\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-2021-5683-0989934
Page 152 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US &
Canada)be changed to 30Oct2020.
Oct-30-2020
15:25:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: Opene
dDMW5230656;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-30-2020
10:17:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answ
eredFUP is froze, please
unfreeze so it can be
updated.
Oct-30-2020
10:13:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Opene
dDate 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
10:13:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/30/
2020Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989935
Page 153 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-16-2021 01:44:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Data updated by site.
Feb-15-2021 10:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered CRF have been
updated with a
FORM level
comment as Not
Applicable.
Feb-12-2021 15:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened eDiary RQ2: V2
vaccination and
corresponding eDiary
data is not available.
However,
V3-‘Symptom
Resolved CRF’ is not
expected to be
completed. Please
review and consider
selecting a FORM
level comment as
'Not Applicable'
instead of item level
comment.
Feb-12-2021 11:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-12-2021 05:06:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened eDiary RQ2: V2
vaccination and
corresponding eDiary
data is not available.
However,
V3-‘Symptom
Resolved CRF’ is not
expected to be
completed. Please
review and consider
to update form level
comment as 'Not
Applicable', else
clarify. Thanks
090177e196ae2ffe\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-2021-5683-0989936
Page 154 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Feb-11-2021 07:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-11-2021 02:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened eDiary RQ1: Thank
you for response.
However, for
'Symptoms' and
'Reactions' the details
are entered as No.
Please review and
consider to update
form level comment
as 'Not Applicable',
else clarify in query
response.
Feb-10-2021 10:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 10:24:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-10-2021 10:24:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-09-2021 07:55:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Vaccination 2
is ‘Not Done’ and
eDiary data not
available however
corresponding
‘Symptom Resolved
CRF’ in visit 3 is
entered with data.
Kindly verify and
consider updating
form level comment
as Not Applicable.
Thanks!
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
090177e196ae2ffe\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-2021-5683-0989937
Page 155 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Feb-15-2021 10:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FEV
ER
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Appl
icabl
eInitial Entry
Feb-15-2021 10:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989938
Page 156 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.b
Date Location User Value Reason
Feb-15-2021 10:05:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATI
GUE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Appl
icabl
eInitial Entry
Feb-15-2021 10:03:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989939
Page 157 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.b Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:03:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-15-2021 10:05:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Appl
icabl
eInitial Entry
Feb-15-2021 10:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
ADInitial Entry
090177e196ae2ffe\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-2021-5683-0989940
Page 158 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.c Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-15-2021 10:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHI
LLS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Appl
icabl
eInitial Entry
Feb-15-2021 10:04:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LSTranscription Error
090177e196ae2ffe\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-2021-5683-0989941
Page 159 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:04:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-15-2021 10:05:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appli
cableInitial Entry
090177e196ae2ffe\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-2021-5683-0989942
Page 160 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Feb-15-2021 10:04:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:04:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-15-2021 10:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EAInitial Entry
090177e196ae2ffe\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-2021-5683-0989943
Page 161 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Appl
icabl
e
Feb-15-2021 10:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
090177e196ae2ffe\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-2021-5683-0989944
Page 162 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Date Location User Value Reason
Feb-15-2021 10:05:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:Not Appli
cableInitial Entry
Feb-15-2021 10:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989945
Page 163 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.g Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:05:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-15-2021 10:06:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:Not Appli
cableInitial Entry
090177e196ae2ffe\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-2021-5683-0989946
Page 164 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
2.h
Date Location User Value Reason
Feb-15-2021 10:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989947
Page 165 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
2.h Symptom:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-10-2021 10:24:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-15-2021 10:06:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-30-2020 10:15:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
090177e196ae2ffe\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-2021-5683-0989948
Page 166 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Feb-15-2021 10:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
Feb-15-2021 10:07:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:07:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ffe\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-2021-5683-0989949
Page 167 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada)
5.b
Date Location User Value Reason
Feb-15-2021 10:07:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:Not
Appli
cableInitial Entry
Feb-15-2021 10:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989950
Page 168 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:07:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-15-2021 10:08:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:Not Ap
plicableInitial Entry
Feb-15-2021 10:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Injection Site Reaction PAIN AInitial Entry
090177e196ae2ffe\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-2021-5683-0989951
Page 169 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada) :: T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-30-2020 10:14:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-15-2021 10:08:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-15-2021 10:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-30-2020 10:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989952
Page 170 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 10:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 10:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 08:04:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 05:48:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-30-2020 10:15:54
(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-30-2020 10:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989953
Page 171 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-02-2020 08:04:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HL8Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 08:04:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HL8Initial Entry
5.b
Date Location User Value Reason
Nov-02-2020 08:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HL9Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 08:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HL9Initial Entry
5.c
Date Location User Value Reason
Nov-02-2020 08:04:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0HLBInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 08:04:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR0HLBInitial Entry
5.d
Date Location User Value Reason
Nov-02-2020 08:05:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS61XMInitial Entry
090177e196ae2ffe\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-2021-5683-0989954
Page 172 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
5.d Sample ID
Date Location User Value Reason
Nov-02-2020 08:05:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS61XMInitial Entry
5.e
Date Location User Value Reason
Nov-02-2020 08:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS61XNInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-02-2020 08:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS61XNInitial Entry
090177e196ae2ffe\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-2021-5683-0989955
Page 173 of 201
***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: 12321213 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-01-2020 13:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Transcription Error
Oct-08-2020 15:50:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020 15:50:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Nov-02-2020 12:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Transcription Error
Nov-02-2020 12:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYTranscription Error
Nov-02-2020 09:47:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Katherine Puig Query 4: Opened DM: Status is
completed but second
vaccination has not
been entered. Please
review and update as
appropriate.
Nov-02-2020 08:05:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDTranscription Error
Oct-14-2020 12:29:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989956
Page 174 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-14-2020 09:10:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Oct-14-2020 09:09:32
(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.
Oct-14-2020 09:09:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-14-2020 09:09:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTTranscription Error
Oct-14-2020 05:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1:Per CRF,
Adverse Event Action
Taken is DRUG
WITHDRAWN but
reason for treatment
discontinuation is not
reported as
ADVERSE EVENT
or DEATH. Kindly
confirm reason for
treatment
discontinuation and
update ‘Status’ as
appropriate on this
page. Else clarify
Oct-13-2020 09:11:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-13-2020 09:11:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYTranscription Error
Oct-13-2020 09:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
090177e196ae2ffe\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-2021-5683-0989957
Page 175 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Oct-13-2020 09:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-13-2020 09:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTTranscription Error
Oct-12-2020 13:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The Adverse
Event Action Taken is
DRUG
WITHDRAWN but
reason for treatment
discontinuation is not
reported as
ADVERSE EVENT
or DEATH. Please
review and clarify.
Oct-08-2020 15:50:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
090177e196ae2ffe\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-2021-5683-0989958
Page 176 of 201
***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: 12321213 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 09:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-10-2020 04:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Closed Response satisfies
query
Nov-09-2020 19:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Nov-09-2020 19:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-09-2020 19:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened CLINQUERY:
Confirmed that
subject will remain in
study (off treatment)
for follow up. Please
therefore update this
page; remove data or
mark as not
applicable. This page
is to indicate end of
study for subjects.
Nov-09-2020 15:53:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Candidate CLINQUERY:
Confirmed that
subject will remain in
study (off treatment)
for follow up. Please
therefore update this
page; remove data or
mark as not
applicable. This page
is to indicate end of
study for subjects.
Nov-01-2020 13:18:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Transcription Error
Oct-27-2020 05:52:50
(UTC-05:00) EasternACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989959
Page 177 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Time (US & Canada)
Oct-26-2020 09:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Oct-26-2020 09:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
Oct-26-2020 09:24:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-24-2020 03:33:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 2: Opened Comment is provided
as "FUP should be
changed to 01Oct2020
(Date) and reason for
discontinuation
should be AE."
Hence, please remove
the form level
comment entered as
"NOT
APPLICABLE" and
enter the disposition
details. Thank you.
Oct-18-2020 03:36:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Item level comment is
entered.
Oct-16-2020 09:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-16-2020 09:24:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-16-2020 09:24:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-16-2020 05:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: As per comment
entered "There was no
Disposition Follow
Up, entered in error.
Cannot removed page
or date", Please
consider updating a
form level comment
of Not Applicable,
090177e196ae2ffe\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)
FDA-CBER-2021-5683-0989960
Page 178 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Thank you.
Oct-13-2020 09:11:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020 09:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-09-2020 19:10:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-26-2020 09:25:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-26-2020 09:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Oct-16-2020 09:24:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-16-2020 09:24:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-13-2020 09:11:24
(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 09:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-10-2020 08:54:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-10-2020 08:49:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989961
Page 179 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-10-2020 08:49:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-10-2020 04:19:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Selection to be
removed from field
(page erased)
Nov-01-2020 14:17:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYTranscription Error
Oct-26-2020 09:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
Oct-26-2020 09:24:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-16-2020 09:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-16-2020 09:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-14-2020 09:11:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTTranscription Error
Oct-13-2020 09:11:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-16-2020 09:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-26-2020 09:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-16-2020 09:24:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ffe\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-2021-5683-0989962
Page 180 of 201
***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: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
Date Location User Value Reason
Oct-02-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0989963
Page 181 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
1. Category:
Date Location User Value Reason
Oct-02-2020 10:25:25
(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-02-2020 10:25:25
(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-07-2020 11:34:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed SDB updated
Nov-05-2020 05:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: Pending
SDB update
Nov-04-2020 10:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AEM form was submitted
Nov-04-2020 06:19:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: Thank you
for the update. Please
confirm if a follow up AEM
form was submitted to
update term in Safety
database
Nov-03-2020 08:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 08:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure during pregnancyTranscription Error
Nov-03-2020 08:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020383635,
the term in both database
was recorded as pregnancy.
090177e196ae2ffe\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-2021-5683-0989964
Page 182 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Based on the latest EDP
guidance,the term should be
reported as 'EXPOSURE
DURING PREGNANCY'.
Please confirm and
update.A follow up AEM
form is required to update
SDB.
Oct-02-2020 10:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-02-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-02-2020 05:33:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-01-2020 14:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Ongoing AE is
pregnancy. Subject
will not continue the
study
Nov-01-2020 13:18:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-27-2020 05:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-26-2020 09:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered FUP should be
changed to
01Oct2020 (Date) and
reason for
discontinuation
should be AE.
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989965
Page 183 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-26-2020 09:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-21-2020 04:37:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Oct-15-2020 09:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Tried to remove data
but it will not allow
me to do so
Oct-15-2020 02:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thanks for the
response. However,
data are still present
in ‘Disposition
Follow-Up' form.
Kindly remove them ;
else clarify.
Oct-14-2020 09:11:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-14-2020 05:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: As per query
response, ‘Disposition
Follow-Up form was
entered in error’,
please consider to
remove details on
Disposition
Follow-Up form and
respond to this query
once action has been
taken. Thank you.
Oct-13-2020 09:14:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Disposition
Follow-Up form was
entered in error
Oct-13-2020 09:11:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
090177e196ae2ffe\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-2021-5683-0989966
Page 184 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-02-2020 10:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 09:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-15-2020 16:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-15-2020 14:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-15-2020 14:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-15-2020 01:41:12
(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-02-2020 10:25:25
(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
Oct-08-2020 20:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Oct-08-2020 15:52:03
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae2ffe\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-2021-5683-0989967
Page 185 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
(US & Canada)
Oct-08-2020 15:52:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOChanged Information
Oct-06-2020 08:06:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed event reported to
Safety
Oct-05-2020 11:47:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened The pregnancy was
appropriately reported
to safety; however,
seriousness criteria is
met only if there is an
abnormal pregnancy
outcome/protocol
section 8.3.5.1. Please
update seriousness
criteria accordingly.
Oct-03-2020 08:42:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
Pregnancy(Onset
date:01Oct2020) 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-02-2020 10:25:25
(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-02-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in deat
h?Initial Entry
090177e196ae2ffe\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-2021-5683-0989968
Page 186 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
NO
Did this serious event require or pr
olong hospitalization?
NO
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
YES
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-02-2020 10:25:25
(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-02-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
PregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0989969
Page 187 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Oct-09-2020 09:14:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Oct-08-2020 15:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-06-2020 15:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Please
complete the EOT tab
of the CRF to capture
end of treatment
Oct-02-2020 10:25:25
(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-02-2020 10:25:25
(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-02-2020 10:25:25
(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
Nov-11-2020 15:55:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 9: Closed Response satisfies
query
Nov-11-2020 15:55:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 8: Closed Response satisfies
query
Nov-11-2020 09:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 9: Answered Pregnancy will be
monitored until
completion
090177e196ae2ffe\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)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0989970
Page 188 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 08:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 9: Opened For AE Exposure during
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".
Nov-11-2020 08:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 8: Answered Transcription Error
Nov-11-2020 08:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNTranscription Error
Nov-11-2020 05:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 8: Opened SAE RECON:
AER#2020383635, the
outcome in AE CRF was
reported as NOT
RECOVERED/NOT
RESOLVED.Based on the
latest EDP guidance, outcome
should be recorded as
UNKNOWN. Please confirm
and update accordingly.
Nov-10-2020 04:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 7: Closed Response satisfies query
Nov-09-2020 15:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 7: Answered Query requested change to
ongoing.
Nov-09-2020 15:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDQuery requested change to
ongoing.
Nov-09-2020 15:29:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 7: Reissued:Opened If the pregnancy is still
ongoing 'recovered/resolved'
should not be checked, please
consider checking ongoing.
Nov-09-2020 10:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 7: Answered Following pregnancy through
until term
090177e196ae2ffe\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-2021-5683-0989971
Page 189 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
Nov-09-2020 07:33:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 7: Opened Outcome is
“RECOVERED/RESOLVED”,
but end date/time is missing.
Please verify and update as
appropriate. Else clarify
Nov-07-2020 10:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies query
Nov-06-2020 14:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6: Closed Close Auto Query
Nov-06-2020 14:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDTranscription Error
Nov-06-2020 09:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6: Opened For AE Exposure during
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".
Nov-06-2020 09:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered Transcription Error
Nov-06-2020 09:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNTranscription Error
Nov-06-2020 06:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 5: Opened Please confirm outcome of the
AE "Exposure during
pregnancy" to be reported
unknown. Thank you.
Nov-03-2020 08:51:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-03-2020 08:51:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDTranscription Error
Nov-03-2020 08:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE Exposure during
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
090177e196ae2ffe\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-2021-5683-0989972
Page 190 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1232 Site Name: (1232) Columbus Regional Research Institute
Subject No: 12321213 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:24
ongoing?" is marked "Yes".
Oct-09-2020 05:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Oct-09-2020 05:20:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Oct-08-2020 16:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered AE is still ongoing patient is
pregnant, when pregnancy is
finished outcome would be
known.
Oct-08-2020 15:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: 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-08-2020 15:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Oct-08-2020 15:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
Oct-05-2020 04:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: The response for "What
was the outcome of this
adverse event?" is missing.
Kindly review and update.
Oct-02-2020 10:26:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-02-2020 10:26:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-02-2020 10:25:25
(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
'Unknown' but End Date/Time
is provided or "Is the adverse
event still ongoing?" is marked
"Yes".
Oct-02-2020 10:25:25 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ffe\Final\Final On: 01-Apr-2021 03:56 (GM
…[truncated]