Document text
Page 1 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001221
Page 2 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/29/2020
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001222
Page 3 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12461035]
2.Birth Date: UNK/UNK/1961
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001223
Page 4 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001224
Page 5 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001225
Page 6 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001226
Page 7 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Dec/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression-stable]
Start Date: Aug/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vision impairment]
Start Date: May/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent headache]
Start Date: May/UNK/2016
Ongoing: YES
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001227
Page 8 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy Penicillin]
Start Date: UNK/UNK/1964
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy sulfas]
Start Date: UNK/UNK/1964
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vasectomy]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001228
Page 9 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001229
Page 10 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
2.Weight: [87.05]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [32.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001230
Page 11 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/29/2020
2.Randomization Number: [264843]
3.Randomization Group: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001231
Page 12 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BM9HDC]
5.bSample ID [BRSSPF]
5.cSample ID [BRSSPG]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001232
Page 13 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BM9HD7]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001233
Page 14 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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/29/2020 10:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001234
Page 15 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001235
Page 16 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001236
Page 17 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001237
Page 18 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: LEFT
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
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001238
Page 19 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001239
Page 20 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BM9HMF]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001240
Page 21 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/20/2020 13:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001241
Page 22 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001242
Page 23 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001243
Page 24 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: LEFT
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
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001244
Page 25 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BM9F4J]
5.bSample ID [BRYBW2]
5.cSample ID [BRYBW3]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001245
Page 26 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001246
Page 27 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001247
Page 28 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001248
Page 29 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001249
Page 30 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001250
Page 31 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001251
Page 32 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001252
Page 33 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001253
Page 34 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001254
Page 35 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001255
Page 36 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001256
Page 37 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001257
Page 38 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001258
Page 39 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001259
Page 40 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001260
Page 41 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001261
Page 42 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001262
Page 43 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001263
Page 44 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
1. ADVERSE
EVENT 1 REFERRED NON-CARDI
AC CHEST PAIN Nov/10/2020 U
NK:UNK NO
End Date Time:
Nov/12/2020 UNK:
UNK
Repeating
Pages
2. ADVERSE
EVENT 2 Hiatus hernia Nov/12/2020 U
NK:UNK YES Repeating
Pages
3. DELETED ADVERSE
EVENT 3 Hiatus hernia Nov/12/2020 U
NK:UNK YES Repeating
Pages
4. ADVERSE
EVENT 4 Reflux esophagitis Nov/12/2020 U
NK:UNK YES Repeating
Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001264
Page 45 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[REFERRED NON-CARDIAC CHEST PAIN]
4.Start Date Time: Nov/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/12/2020 UNK:UNK
6.Toxicity Grade: 3
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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:
[Non Cardiac chest pain related to gastro-esophageal reflux pathology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001265
Page 46 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020454517]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001266
Page 47 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hiatus hernia]
4.Start Date Time: Nov/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]Comments
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001267
Page 48 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001268
Page 49 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hiatus hernia ]
4.Start Date Time: Nov/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001269
Page 50 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001270
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Reflux esophagitis]
4.Start Date Time: Nov/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hiatus hernia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001271
Page 52 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001272
Page 53 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001273
Page 54 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001274
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001275
Page 56 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: //
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001276
Page 57 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001277
Page 58 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001278
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001279
Page 60 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001280
Page 61 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001281
Page 62 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001282
Page 63 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001283
Page 64 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001284
Page 65 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001285
Page 66 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001286
Page 67 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001287
Page 68 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001288
Page 69 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001289
Page 70 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001290
Page 71 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001291
Page 72 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001292
Page 73 of 165
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001293
Page 74 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001294
Page 75 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001295
Page 76 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001296
Page 77 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001297
Page 78 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001298
Page 79 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/17/2020
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001299
Page 80 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001300
Page 81 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany Musungaie Approved Feb-04-2021 19:18:50 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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.
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001301
Page 82 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormSep-30-2020 15:12:11 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001302
Page 83 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
9Nov-17-2020 14:42:16 (UTC+02:00) Harare,
PretoriaUnknown
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001303
Page 84 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany Musungaie Approved Feb-04-2021 19:18:50 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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 Feb-04-2021 12:40:27 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Dec-23-2020 11:02:41 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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-23-2020 08:52:10 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Dec-02-2020 07:29:25 (UTC+02:00) Harare,
PretoriaBOOK Signed
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001304
Page 85 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-02-2020 07:13:12 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Nov-27-2020 07:20:34 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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-25-2020 08:23:49 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Nov-24-2020 18:21:34 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-23-2020 08:16:17 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001305
Page 86 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
N/A
Dany Musungaie Approved Nov-17-2020 19:36:14 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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-17-2020 10:00:21 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Nov-16-2020 18:56:24 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, 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-16-2020 16:35:48 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany Musungaie Approved Nov-12-2020 18:33:42 (UTC+02:00) Harare,
PretoriaBOOK Signed
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001306
Page 87 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, DanyMusungaie, 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.
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001307
Page 88 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-29-2020 11:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-29-2020 11:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001308
Page 89 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-29-2020 11:01:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/29/2020Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001309
Page 90 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-29-2020 10:59:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12461035Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-29-2020 10:58:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-29-2020 11:01:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-29-2020 11:01:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-29-2020 11:01:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001310
Page 91 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 11:01:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001311
Page 92 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-29-2020 11:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-29-2020 11:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-29-2020 11:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001312
Page 93 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-29-2020 11:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Hypercholesterol
emia
Start Date: Dec/UNK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-29-2020 11:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Dec/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-29-2020 11:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-29-2020 11:03:19 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001313
Page 94 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
Pretoria(autocalc) Line/MH Number: 2
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
08
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:03:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:03:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-29-2020 11:03:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-29-2020 11:03:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-29-2020 11:03:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Depression-sta
ble
Start Date: Aug/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001314
Page 95 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:03:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:03:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Depression-stableInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-29-2020 11:03:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Aug/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-29-2020 11:03:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-29-2020 11:04:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Vision impairm
ent
Start Date: May/UNK/2017
Ongoing: YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001315
Page 96 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:04:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:04:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Vision impairmentInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-29-2020 11:04:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
May/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-29-2020 11:04:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-29-2020 11:05:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Intermittent head
ache
Start Date: May/UNK/2016
Ongoing: YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001316
Page 97 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:05:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:05:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Intermittent headacheInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-29-2020 11:05:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
May/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-29-2020 11:05:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-29-2020 11:05:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Allergy Penicill
in
Start Date: UNK/UNK/196
4
Ongoing: YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001317
Page 98 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:05:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:05:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Allergy PenicillinInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-29-2020 11:05:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/1964Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-29-2020 11:05:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-29-2020 11:06:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Allergy sulfas
Start Date: UNK/UNK/19
64
Ongoing: YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001318
Page 99 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.g Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:06:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:06:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Allergy sulfasInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-29-2020 11:06:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/1964Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-29-2020 11:06:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-29-2020 11:06:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Vasectomy
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2
012Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001319
Page 100 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.h Line/MH Number:
Date Location User Value Reason
Sep-29-2020 11:06:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 11:06:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
VasectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-29-2020 11:06:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-29-2020 11:06:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001320
Page 101 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-29-2020 11:06:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001321
Page 102 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
87.05Initial Entry
3. Unit:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
164.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.4Initial Entry
7.a
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001322
Page 103 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-29-2020 11:07:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001323
Page 104 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-29-2020 11:08:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-29-2020 11:08:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
264843Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001324
Page 105 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 11:08:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 11:08:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 12:34:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 11:08:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-29-2020 11:08:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 12:34:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9HDCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 12:34:00 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001325
Page 106 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
PretoriaBM9HDC
5.b
Date Location User Value Reason
Sep-29-2020 12:34:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSSPFInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 12:34:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSSPFInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 12:34:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSSPGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 12:34:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSSPGInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001326
Page 107 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 11:08:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 11:08:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 12:35:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 11:08:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-29-2020 11:08:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 12:35:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9HD7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 12:35:04 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001327
Page 108 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
PretoriaBM9HD7
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1001328
Page 109 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/29/2020 10:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001329
Page 110 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-29-2020 11:11:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001330
Page 111 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-29-2020 11:35:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001331
Page 112 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 12:58:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001332
Page 113 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001333
Page 114 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001334
Page 115 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001335
Page 116 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001336
Page 117 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-20-2020 13:00:06 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001337
Page 118 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
Pretoria(autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000
)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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001338
Page 119 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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-20-2020 13:00:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001339
Page 120 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2.a
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-20-2020 13:00:45
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001340
Page 121 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1001341
Page 122 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:25:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:25:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:26:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:25:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-20-2020 13:25:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:26:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9HMFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:26:03 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001342
Page 123 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
PretoriaBM9HMF
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001343
Page 124 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/20/2020 13:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001344
Page 125 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-20-2020 13:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001345
Page 126 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 10:00:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001346
Page 127 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001347
Page 128 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001348
Page 129 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001349
Page 130 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001350
Page 131 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-17-2020 10:01:01 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001351
Page 132 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
Pretoria(autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001352
Page 133 of 165
***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, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 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
Nov-17-2020 10:01:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001353
Page 134 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 11:47:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 11:47:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 11:47:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 11:47:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-17-2020 11:47:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 11:47:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9F4JInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 11:47:15 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1001354
Page 135 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00) Harare,
PretoriaBM9F4J
5.b
Date Location User Value Reason
Nov-17-2020 11:47:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRYBW2Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-17-2020 11:47:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRYBW2Initial Entry
5.c
Date Location User Value Reason
Nov-17-2020 11:47:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRYBW3Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-17-2020 11:47:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRYBW3Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001355
Page 136 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001356
Page 137 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001357
Page 138 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-24-2020 10:52:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Deleted Duplicate entry
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001358
Page 139 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001359
Page 140 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-23-2020
08:52:10
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
REFE
RRE
D NO
N-CA
RDIA
C CH
EST P
AINChanged as requested by
Clinician
Dec-02-2020
07:50:58
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
4: Clo
sedDiscrepancy has been
closed.
Dec-02-2020
07:13:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query (autoquery) Query
4: Ans
weredTranscription Error
Dec-02-2020
07:13:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
3: Del
etedTranscription Error
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001360
Page 141 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-02-2020
07:13:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
REFE
RRE
D CH
EST P
AIN
RELA
TED
TO G
ASTR
O-ES
OPH
AGE
AL R
EFLU
X PAT
HOL
OGYTranscription Error
Dec-01-2020
18:08:08
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
4: Rei
ssued:
Opene
dPlease check spelling of the
term. Are you reporting
REFERRED CHEST PAIN
RELATED TO GASTRO-
ESOPHAGEAL REFLUX
PATHOLOGY? If so,
update the verbatim term as
such. Otherwise split the
current term into
REFERRED CHEST PAIN
and GASTRIC
PATHOLOGY
Nov-27-2020
07:43:42
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
4: Ans
weredDiagnosis as per
cardiologist report:
Referred chest pain of
gastro gastro-esophageal
pathology
Nov-27-2020
03:43:54
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
3: Rei
ssued:
Candi
datePending Clinical review of
term
Nov-26-2020
16:56:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
4: Op
enedClarify REFERRED
CHEST PAIN OF
GASTRO GASTRO-
ESOPHAGEAL
PATHOLOGY as
follows...Are you reporting
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001361
Page 142 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
REFERRED CHEST PAIN
RELATED TO GASTRO-
ESOPHAGEAL REFLUX
PATHOLOGY? If so,
update the verbatim term as
such. Otherwise split the
current term into
REFERRED CHEST PAIN
and GASTRIC
PATHOLOGY and
ESOPHAGEAL
PATHOLOGY and submit
as 3 separate entries. Thank
you.
Nov-26-2020
15:44:17
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query (autoquery) Query
3: Ans
weredChanged as requested
Nov-26-2020
15:44:17
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
Referr
ed che
st pain
of gas
tro ga
stro-e
sopha
geal p
atholo
gyChanged as requested
Nov-26-2020
14:07:04
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
3: Op
enedSAE
RECON:AER#2020454517
The term was updated to
'Referred chest pain of
gastro-esophageal
pathology' in Safety
database. Please confirm
correct term and consider
to split the term in AE CRF
to match Safety database.
Nov-24-2020
20:06:55
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Clo
sedDiscrepancy has been
closed.
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001362
Page 143 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-24-2020
18:17:08
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query (autoquery) Query
2: Ans
weredChanged Information
Nov-24-2020
18:17:08
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
Non C
ardiac
Chest
pain r
elated
to gast
ro-eso
phage
al refl
ux pat
holog
yChanged Information
Nov-24-2020
16:15:22
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Op
enedClarify NON CARDIAC
CHEST PAIN
(REFERRED CHEST
PAIN OF GASTRO-
ESOPHAGEAL
PATHOLOGY) as
follows...Are you reporting
NON CARDIAC CHEST
PAIN RELATED TO
GASTRO-ESOPHAGEAL
REFLUX PATHOLOGY?
If so, update the verbatim
term as such. Otherwise
clarify and edit the term.
Thank you.
Nov-24-2020
16:05:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Giselle Castillo Query
1: Clo
sedResponse satisfies query
Nov-24-2020
10:51:08
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query (autoquery) Query
1: Ans
weredChanged Information
Nov-24-2020
10:51:08ACV0PFEINFP6000 Data
EntryChanged Information
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001363
Page 144 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare,
Pretoria:
Non C
ardiac
Chest
pain (
Referr
ed che
st pain
of gas
tro-es
ophag
eal pat
holog
y)
Nov-23-2020
17:01:46
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Giselle Castillo Query
1: Rei
ssued:
Opene
dThe page has been
unfrozen. Thank you.
Nov-22-2020
20:45:39
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
1: Ans
weredplease unfreeze to update
Nov-21-2020
01:14:56
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Giselle Castillo Query
1: Op
enedKindly clarify if this is a
non-cardiac vs cardiac
chest pain since it has been
recorded that it is related to
Med Hx of hypertension
and hypercholesterolemia.
please provide final
diagnosis and update AE
log accordingly. Thank
you.
Nov-16-2020
16:35:48
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
Chest
painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/10/2020 UNK:UNKInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001364
Page 145 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
3Initial 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
Nov-17-2020 16:59:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Closed Per PSSR confirmation
during the meeting,
SAE form received.
Event reported under
AER 2020454517
Nov-17-2020 15:10:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Reissued:Candidate PSSR confirmation
Nov-17-2020 14:30:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Answered Was reported to Safety:
Reference number
2020454517
Nov-17-2020 14:22:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed missing in SDB
Nov-17-2020 14:22:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Opened SAE RECON: Chest
pain(Onset
date:10Nov2020) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001365
Page 146 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Nov-17-2020 12:54:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened For AE Chest pain:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Chest pain:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
ventInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001366
Page 147 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-25-2020 11:54:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Nov-25-2020 08:23:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-25-2020 08:23:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
Non Cardiac chest pain related
to gastro-esophageal reflux pat
hologyNew Information
Nov-24-2020 19:25:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: can you
please review the
relatedness field of
the AE and update
according to the AE
term "Non Cardiac
Chest pain related to
gastro-esophageal
reflux pathology".
Thanks
Nov-16-2020 16:37:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:Changed Information
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001367
Page 148 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
OTHER
If Other, specify:
Hypercholesterolemia and hyp
ertension medical history
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 16:35:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001368
Page 149 of 165
***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, Not Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-17-2020 16:59:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2020454517Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001369
Page 150 of 165
***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, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-24-2020 16:05:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Nov-24-2020 10:53:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered Entered as requested
Nov-23-2020 17:02:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened The form has been
unfrozen. Thank you.
Nov-22-2020 20:46:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered please unfreeze to
update
Nov-21-2020 01:19:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Per narrative, the
participant was
diagnosed with reflux
esophagitis. If this is
an additional event,
please revise and
update AE log
accordingly. Thank
you.
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Hiatus herniaInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1001370
Page 151 of 165
***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, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-08-2020 21:40:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-08-2020 07:55:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered Ongoing
Dec-07-2020 19:55:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened GPD CLIN: Please
confirm if event is
still ongoing. If
resolved, please add
stop date. Thank you!
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001371
Page 152 of 165
***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, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-17-2020 14:43:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
UnknownNew Information
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001372
Page 153 of 165
***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, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-17-2020 14:41:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001373
Page 154 of 165
***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, Deleted
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Hiatus herniaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001374
Page 155 of 165
***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, Deleted
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001375
Page 156 of 165
***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, Deleted
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020 08:16:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001376
Page 157 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Reflux esophagitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-08-2020 21:41:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-08-2020 07:58:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered Ongoing
Dec-07-2020 20:11:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened GPD CLIN: Please
confirm if event is
still ongoing. If
resolved, please add
stop date. Thank you!
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001377
Page 158 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
Hiatus herniaInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001378
Page 159 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020 08:17:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (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-2021-5683-1001379
Page 160 of 165
***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: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-17-2020 10:22:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-17-2020 10:22:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020 10:22:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001380
Page 161 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 12:40:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001381
Page 162 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 12:41:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 12:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-04-2021 12:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible and NOT confirmed to hav
e received only placebo at Vaccinat
ion 1/2Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001382
Page 163 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 12:41:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 12:41:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001383
Page 164 of 165
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-17-2020 10:22:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-29-2020 11:08:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-29-2020 11:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-17-2020 10:22:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/17/2020Initial Entry
Sep-29-2020 11:08:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
Sep-29-2020 11:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001384
Page 165 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-12-2020 12:23:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae302b\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001385