Document text
Page 1 of 194
***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: 12461131 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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001895
Page 2 of 194
***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: 12461131 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
Oct/10/2020
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001896
Page 3 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12461131]
2.Birth Date: UNK/UNK/1986
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001897
Page 4 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/10/2020
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001898
Page 5 of 194
***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: 12461131 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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001899
Page 6 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001900
Page 7 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:[Hysterectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Endometriosis uterus]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001901
Page 8 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Endometriosis left ovary]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001902
Page 9 of 194
***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: 12461131 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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001903
Page 10 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/10/2020
2.Weight: [79.8]
3.Unit: kg
4.Height: [171.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001904
Page 11 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001905
Page 12 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/10/2020
2.Randomization Number: [105789]
3.Randomization Group: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001906
Page 13 of 194
***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: 12461131 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:
Oct/10/2020
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 [BM9HKV]
5.bSample ID [BRSSX6]
5.cSample ID [BRSSX5]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001907
Page 14 of 194
***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: 12461131 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/10/2020
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 [BM9HKL]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001908
Page 15 of 194
***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: 12461131 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/10/2020 08:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001909
Page 16 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001910
Page 17 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/31/2020
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001911
Page 18 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001912
Page 19 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001913
Page 20 of 194
***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: 12461131 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/31/2020
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 [BM9DW5]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001914
Page 21 of 194
***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: 12461131 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/31/2020 08:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001915
Page 22 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/28/2020
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001916
Page 23 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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/28/2020
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 [BM9DZR]
5.bSample ID [BRYC2D]
5.cSample ID [BRYC2C]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001917
Page 24 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001918
Page 25 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001919
Page 26 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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 [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001920
Page 27 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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 [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001921
Page 28 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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?
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001922
Page 29 of 194
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001923
Page 30 of 194
***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: 12461131 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:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001924
Page 31 of 194
***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: 12461131 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 [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001925
Page 32 of 194
***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: 12461131 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:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001926
Page 33 of 194
***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: 12461131 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 [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001927
Page 34 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001928
Page 35 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001929
Page 36 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Worsening of Endo
metriosis left ovary Jan/6/2021
UNK:UNK NO
End Date Time:
Jan/20/2021 10:
31
Repeating
Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001930
Page 37 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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)[Worsening of Endometriosis left ovary]
4.Start Date Time: Jan/6/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 10:31
6.Toxicity Grade: 3
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001931
Page 38 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001932
Page 39 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant
Medication given?YES
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[2021063190]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001933
Page 40 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001934
Page 41 of 194
***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: 12461131 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[ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001935
Page 42 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001936
Page 43 of 194
***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: 12461131 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: //
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001937
Page 44 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001938
Page 45 of 194
***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: 12461131 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?
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001939
Page 46 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001940
Page 47 of 194
***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: 12461131 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?
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001941
Page 48 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001942
Page 49 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001943
Page 50 of 194
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001944
Page 51 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001945
Page 52 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001946
Page 53 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001947
Page 54 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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?
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001948
Page 55 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001949
Page 56 of 194
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001950
Page 57 of 194
***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: 12461131 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: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001951
Page 58 of 194
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001952
Page 59 of 194
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12461131 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 per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001953
Page 60 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001954
Page 61 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001955
Page 62 of 194
***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: 12461131 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: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001956
Page 63 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/27/2021
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001957
Page 64 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/27/2021
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001958
Page 65 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001959
Page 66 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001960
Page 67 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001961
Page 68 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:
Feb/27/2021
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 [BRST42]
5.bSample ID [BRST41]
5.cSample ID [BR7N78]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001962
Page 69 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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:
Feb/27/2021
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 [BR7N77]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001963
Page 70 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/27/2021 08:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001964
Page 71 of 194
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001965
Page 72 of 194
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001966
Page 73 of 194
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 12461131 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 [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001967
Page 74 of 194
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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?
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001968
Page 75 of 194
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001969
Page 76 of 194
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001970
Page 77 of 194
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001971
Page 78 of 194
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001972
Page 79 of 194
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001973
Page 80 of 194
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001974
Page 81 of 194
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001975
Page 82 of 194
***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: 12461131 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/28/2020
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001976
Page 83 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001977
Page 84 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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 Mar-02-2021 18:10:37 (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.
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001978
Page 85 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-10-2020 11:48:28 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001979
Page 86 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-10-2020 12:51:44 (UTC+02:00)
Harare, PretoriaN/A had hysterectomy
FormOct-10-2020 12:51:29 (UTC+02:00)
Harare, PretoriaN? had hysterectomy
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001980
Page 87 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-10-2020 12:52:16 (UTC+02:00)
Harare, Pretoriahad hysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001981
Page 88 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-10-2020 12:53:00 (UTC+02:00)
Harare, Pretorian/a had hysterectomy
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001982
Page 89 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-10-2020 12:53:00 (UTC+02:00)
Harare, Pretorian/a had hysterectomy
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001983
Page 90 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-10-2020 12:53:00 (UTC+02:00)
Harare, Pretorian/a had hysterectomy
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001984
Page 91 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001985
Page 92 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001986
Page 93 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001987
Page 94 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001988
Page 95 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001989
Page 96 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001990
Page 97 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001991
Page 98 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001992
Page 99 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-31-2020 08:42:01 (UTC+02:00)
Harare, PretoriaHysterectomy
Not Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001993
Page 100 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormFeb-27-2021 09:07:38 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001994
Page 101 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormFeb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001995
Page 102 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Feb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001996
Page 103 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Feb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001997
Page 104 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Feb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001998
Page 105 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Feb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1001999
Page 106 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Feb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1002000
Page 107 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aFeb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002001
Page 108 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aFeb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002002
Page 109 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aFeb-27-2021 09:11:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002003
Page 110 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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 Mar-02-2021 18:10:37 (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 Mar-01-2021 15:41:53 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-27-2021 11:35:33 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1002004
Page 111 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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 Feb-27-2021 09:06:40 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-08-2021 19:27:07 (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.
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1002005
Page 112 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
N/A Feb-08-2021 12:20:14 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-28-2021 14:35:34 (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 Jan-28-2021 10:08:30 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-27-2021 19:30:59 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1002006
Page 113 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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 Jan-27-2021 07:42:41 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-25-2021 19:34:02 (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.
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1002007
Page 114 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
N/A Jan-22-2021 13:00:27 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Dec-02-2020 07:25:02 (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-28-2020 09:47:50 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-18-2020 11:55:58 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1002008
Page 115 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12461131 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.
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002009
Page 116 of 194
***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: 12461131 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
Oct-10-2020
11:47:35
(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
Oct-10-2020
11:47:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002010
Page 117 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-10-2020
11:47:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/10/2020Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002011
Page 118 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-10-2020
11:47:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12461131Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-10-2020
11:47:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1986Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-10-2020
11:48:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-10-2020
11:48:00
(UTC+02:00)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OFInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002012
Page 119 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-10-2020
11:48:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BLACK OR AFRICA
N AMERICANInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002013
Page 120 of 194
***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: 12461131 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-10-2020
11:48:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002014
Page 121 of 194
***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: 12461131 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
Oct-10-2020
11:48:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-10-2020
11:48:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-10-2020
11:48:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002015
Page 122 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-10-2020
11:52:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Hysterecto
my
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
UNK/U
NK/201
7Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-10-2020
11:52:10
(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
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002016
Page 123 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-10-2020
11:52:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
HysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-10-2020
11:52:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-10-2020
11:52:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Jan-27-2021
07:42:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Endometri
osis uterusInitial Entry
090177e196ae302c\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-2021-5683-1002017
Page 124 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
UNK/U
NK/201
7
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002018
Page 125 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Jan-27-2021
07:42:41
(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
Jan-27-2021
07:42:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Endometriosis uterusInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-27-2021
07:42:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-27-2021
07:42:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae302c\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-2021-5683-1002019
Page 126 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c
Date Location User Value Reason
Jan-27-2021
07:45:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Endometrio
sis left ovar
y
Start Dat
e:UNK/UNK
/2017
Ongoing: NO
End Date:
UNK/U
NK/201
7Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002020
Page 127 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Jan-27-2021
07:45:01
(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
Jan-27-2021
07:45:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Endometriosis left ova
ryInitial Entry
1.c Start Date:
Date Location User Value Reason
Jan-27-2021
07:45:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jan-27-2021
07:45:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae302c\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-2021-5683-1002021
Page 128 of 194
***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: 12461131 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
Oct-10-2020
11:52:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002022
Page 129 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
79.8Initial Entry
3. Unit:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-10-2020
11:54:30ACV0PFEINFP6000 Data Entry:
171.0Initial Entry
090177e196ae302c\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-2021-5683-1002023
Page 130 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Unit:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.3Initial Entry
7.a
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.6
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002024
Page 131 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-10-2020
11:54:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302c\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-2021-5683-1002025
Page 132 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-10-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1002026
Page 133 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
12:52:16
(UTC+02:00)
Harare, PretoriaNot Applicable
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-10-2020
12:29:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of
collection is
reported, but
result is
missing. Please
review and
update as
appropriate.
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
090177e196ae302c\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-2021-5683-1002027
Page 134 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-10-2020
12:29:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-10-2020
12:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:113
Test:: Choriogon
adotropin
Beta_PX1
13
Result::Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002028
Page 135 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Not Don
e::NOT DO
NE
Oct-10-2020
12:29:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:
Test:: Choriogon
adotropin
Beta_PX1
13
Result::
Not Don
e::Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:113
Test:: Choriogon
adotropin
Beta_PX1
13
Result:: NEGATIV
E
Not Don
e::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002029
Page 136 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-10-2020
12:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
Oct-10-2020
12:29:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-10-2020
11:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-10-2020
12:29:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-10-2020
11:54:51
(UTC+02:00)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae302c\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-2021-5683-1002030
Page 137 of 194
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
6.a Not Done:
Date Location User Value Reason
Oct-12-2020
21:26:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Query 1: Closed issued in error
Oct-12-2020
21:25:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Subject is less
than 60 years
old and it is not
clear from her
medhx why a
pregnancy test
was not
performed.
Please review
and update the
MedHx log as
appropriate else
clarify. Thank
you.
Oct-10-2020
12:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae302c\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-2021-5683-1002031
Page 138 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-10-2020
11:55:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-10-2020
11:55:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
105789Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002032
Page 139 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-10-2020
14:20:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-10-2020
14:20:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-10-2020
14:21:08
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-10-2020
14:20:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002033
Page 140 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-10-2020
14:20:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/10/2020Initial Entry
5.a
Date Location User Value Reason
Oct-10-2020
14:21:08
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BM9HK
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-10-2020
14:21:08
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BM9HKVInitial Entry
5.b
Date Location User Value Reason
Oct-10-2020
14:21:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSSX6Initial Entry
090177e196ae302c\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-2021-5683-1002034
Page 141 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Oct-10-2020
14:21:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRSSX6Initial Entry
5.c
Date Location User Value Reason
Oct-10-2020
14:22:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSSX5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-10-2020
14:22:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRSSX5Initial Entry
090177e196ae302c\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-2021-5683-1002035
Page 142 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-10-2020
14:22:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-10-2020
14:22:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-10-2020
14:23:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-10-2020
14:22:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002036
Page 143 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-10-2020
14:22:41
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/10/2020Initial Entry
5.a
Date Location User Value Reason
Oct-10-2020
14:23:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BM9HK
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-10-2020
14:23:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BM9HKLInitial Entry
090177e196ae302c\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-2021-5683-1002037
Page 144 of 194
***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: 12461131 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-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)ACV0PFEINFP6000 Data Entry:
Oct/10/2020 08:50Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002038
Page 145 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002039
Page 146 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-10-2020
11:55:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002040
Page 147 of 194
***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: 12461131 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
Oct-10-2020
11:56:23
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002041
Page 148 of 194
***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: 12461131 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-31-2020
08:41:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/31/2020Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002042
Page 149 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Oct/31/2020Initial Entry
2.a
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.6
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae302c\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-2021-5683-1002043
Page 150 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-31-2020
08:41:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302c\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-2021-5683-1002044
Page 151 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-31-2020
08:42:01ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae302c\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-2021-5683-1002045
Page 152 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Specimen Type:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifie
r:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae302c\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-2021-5683-1002046
Page 153 of 194
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-31-2020
08:42:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae302c\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)
(6)
FDA-CBER-2021-5683-1002047
Page 154 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-31-2020
08:42:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-31-2020
08:42:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-31-2020
08:42:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-31-2020
08:42:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002048
Page 155 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-31-2020
08:42:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/31/2020Initial Entry
5.a
Date Location User Value Reason
Oct-31-2020
08:42:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BM9DW
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-31-2020
08:42:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BM9DW5Initial Entry
090177e196ae302c\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-2021-5683-1002049
Page 156 of 194
***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: 12461131 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-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)ACV0PFEINFP6000 Data Entry:
Oct/31/2020 08:24Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002050
Page 157 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-31-2020
08:42:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002051
Page 158 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-31-2020
09:01:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002052
Page 159 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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-28-2020
09:47:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1002053
Page 160 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-28-2020
09:48:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-28-2020
09:48:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-28-2020
09:48:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-28-2020
09:48:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002054
Page 161 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Nov-28-2020
09:48:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/28/2020Initial Entry
5.a
Date Location User Value Reason
Nov-28-2020
09:48:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BM9DZ
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-28-2020
09:48:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BM9DZRInitial Entry
5.b
Date Location User Value Reason
Nov-28-2020
09:48:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BRYC2DInitial Entry
090177e196ae302c\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-2021-5683-1002055
Page 162 of 194
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Nov-28-2020
09:48:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRYC2DInitial Entry
5.c
Date Location User Value Reason
Nov-28-2020
09:48:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRYC2CInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-28-2020
09:48:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRYC2CInitial Entry
090177e196ae302c\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-2021-5683-1002056
Page 163 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002057
Page 164 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021
13:00:27
(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 Value Reason
Feb-10-2021
21:49:26
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 3:
ClosedSDB updated
Feb-05-2021
07:34:43
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 3:
AnsweredWas changed as requested
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002058
Page 165 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Feb-04-2021
20:17:30
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 3:
Reissued:
OpenedSAE RECON 1: SAE term
in both Safety database and
CRF is expected to match.
Please review and update
the appropriate database
with the correct term.
Feb-02-2021
08:45:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 3:
AnsweredDiagnosis changed on SAE
Feb-01-2021
19:39:56
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 3:
OpenedSAE
RECON:AER#2021063190,
the term in AE CRF was
updated to 'Worsening of
Endometriosis left ovary'
while retained as
'Endometriosis left ovary' in
SDB. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Feb-01-2021
18:55:39
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Giselle
CastilloQuery 2:
ClosedResponse satisfies query
Jan-28-2021
10:08:30
(UTC+02:00)
Harare,ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredChanged Information
090177e196ae302c\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)
FDA-CBER-2021-5683-1002059
Page 166 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria
Jan-28-2021
10:08:30
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data Ent
ry:
Worsenin
g of Endo
metriosis
left ovaryChanged Information
Jan-27-2021
21:04:41
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1:
ClosedResponse satisfies query
Jan-27-2021
16:46:37
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Giselle
CastilloQuery 2:
OpenedPer CRF completion
requirements V12 section
8.50.2.3. If the event of
Endometriosis left ovary is
an intermittent AE (as
reported on Med Hx) the
new episodes should be
recorded as “worsening
of…”. Please update event
term accordingly.
Jan-27-2021
07:45:51
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 1:
AnsweredAdded in medical history
Jan-26-2021
21:55:14
(UTC+02:00)
Harare,ACV0PFEINFP6000 Svitlana
TonkovydQuery 1:
Reissued:
OpenedGPD Clin: MH eCRF is
now unlocked. Many thanks
for updating as per previous
query response.
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1002060
Page 167 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria
Jan-26-2021
11:28:33
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 1:
AnsweredThank you- waiting for MH
page
Jan-25-2021
19:54:39
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1:
Reissued:
OpenedThanks for confirming
presence of MH item.
Request to unlock MH page
has been posted. Please
update MH page once
unlocked. Thank you
Jan-25-2021
11:26:28
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 1:
AnsweredPatient had a hysterectomy
2017 due to Endometriosis.
Site can't enter medical
history- page is locked.
Jan-22-2021
17:48:01
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1:
OpenedGPD CLIN: Does subject
have a history of
Endometriosis? If yes,
please update medical
history CRF. Thank you.
Jan-22-2021
13:00:27
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data Ent
ry:
Endometr
iosis left
ovaryInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae302c\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-2021-5683-1002061
Page 168 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Jan/6/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/20/2021 10:31Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021
13:00:27
(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
090177e196ae302c\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-2021-5683-1002062
Page 169 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-25-2021
17:43:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Endometriosis
left ovary:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prolo
ng hospitalization?Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002063
Page 170 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
NO
Other medically im
portant serious eve
nt
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
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002064
Page 171 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae302c\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) (6)
FDA-CBER-2021-5683-1002065
Page 172 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13:00:27
(UTC+02:00)
Harare, PretoriaYES
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021
13:00:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-25-2021
17:43:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
2021063190Initial Entry
090177e196ae302c\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)
(6)
FDA-CBER-2021-5683-1002066
Page 173 of 194
***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, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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-30-2020
08:12:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-30-2020
08:12:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-30-2020
08:12:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002067
Page 174 of 194
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12461131 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-08-2021
12:20:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Feb/5/2021Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002068
Page 175 of 194
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-08-2021
12:36:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-08-2021
12:20:27
(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-08-2021
12:20:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible per other
protocol allowan
ce(s) and confirm
ed to have receiv
ed only placebo aInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002069
Page 176 of 194
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
t Vaccination 1/2
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002070
Page 177 of 194
***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: 12461131 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-08-2021
12:36:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Feb/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-08-2021
12:36:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1002071
Page 178 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 12461131 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-27-2021
09:06:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Feb/27/2021Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002072
Page 179 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-27-2021
09:07:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/27/2021Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002073
Page 180 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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
Feb-27-2021
09:08:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Feb/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-27-2021
09:08:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENIN
G 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-27-2021
09:08:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002074
Page 181 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-27-2021
09:11:13ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae302c\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-2021-5683-1002075
Page 182 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Specimen Type:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae302c\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-2021-5683-1002076
Page 183 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-27-2021
09:11:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae302c\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-2021-5683-1002077
Page 184 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021
09:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021
09:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-27-2021
09:37:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-27-2021
09:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002078
Page 185 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Feb-27-2021
09:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Feb/27/2021Initial Entry
5.a
Date Location User Value Reason
Feb-27-2021
09:37:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BRST4
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-27-2021
09:37:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRST42Initial Entry
5.b
Date Location User Value Reason
Feb-27-2021
09:37:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BRST4
1Initial Entry
090177e196ae302c\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-2021-5683-1002079
Page 186 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Feb-27-2021
09:37:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BRST41Initial Entry
5.c
Date Location User Value Reason
Feb-27-2021
09:38:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID
:BR7N7
8Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-27-2021
09:38:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BR7N78Initial Entry
090177e196ae302c\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-2021-5683-1002080
Page 187 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021
09:38:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021
09:38:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
15:41:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-01-2021
12:47:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002081
Page 188 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Feb-27-2021
09:38:34
(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.
Feb-27-2021
09:38:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Feb/27/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
15:41:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BR7N77Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
15:41:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
BR7N77Initial Entry
090177e196ae302c\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-2021-5683-1002082
Page 189 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 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
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)ACV0PFEINFP6000 Data Entry:
Feb/27/2021 08:30Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002083
Page 190 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002084
Page 191 of 194
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9. Unit:
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-27-2021
09:10:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002085
Page 192 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-30-2020
08:12:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-10-2020
11:55:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-10-2020
11:48:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-30-2020
08:12:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/28/2020Initial Entry
Oct-10-2020
11:55:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/10/2020Initial Entry
Oct-10-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002086
Page 193 of 194
***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: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11:48:50
(UTC+02:00)
Harare, Pretoria(autocalc) Oct/10/2020
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1002087
Page 194 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-18-2020
11:32:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae302c\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1002088