125742 S1 M5 CRF c4591001 1246 12461110

Document text

Page 1 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001717
Page 2 of 178
***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: 12461110 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/7/2020
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001718
Page 3 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12461110]
2.Birth Date: UNK/UNK/2001
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001719
Page 4 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001720
Page 5 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001721
Page 6 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001722
Page 7 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001723
Page 8 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001724
Page 9 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
2.Weight: [90.65]
3.Unit: kg
4.Height: [184.25]
5.Unit: cm
6.Body Mass Index: [26.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001725
Page 10 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/7/2020
2.Randomization Number: [104534]
3.Randomization Group: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001726
Page 11 of 178
***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: 12461110 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/7/2020
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 [BM9HJB]
5.bSample ID [BRSSVX]
5.cSample ID [BRSSVY]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001727
Page 12 of 178
***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: 12461110 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/7/2020
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 [BM9HJ8]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001728
Page 13 of 178
***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: 12461110 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/7/2020 14:55
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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001729
Page 14 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001730
Page 15 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001731
Page 16 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001732
Page 17 of 178
***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: 12461110 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/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 [BM9DVC]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001733
Page 18 of 178
***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: 12461110 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/28/2020 09:00
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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001734
Page 19 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/25/2020
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001735
Page 20 of 178
***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: 12461110 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/25/2020
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 [BM9DYN]
5.bSample ID [BRYBZY]
5.cSample ID [BRYBZZ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001736
Page 21 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001737
Page 22 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001738
Page 23 of 178
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001739
Page 24 of 178
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001740
Page 25 of 178
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001741
Page 26 of 178
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001742
Page 27 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001743
Page 28 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/6/2021
2.Date of First Symptom
Started:Jan/3/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/27/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001744
Page 29 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001745
Page 30 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jan/6/2
021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001746
Page 31 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/6/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [Local lab Ampath ISO15189 accredited]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001747
Page 32 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Site visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001748
Page 33 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 12461110 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:
Jan/6/2021
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 [BM9F0G]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001749
Page 34 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001750
Page 35 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001751
Page 36 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001752
Page 37 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001753
Page 38 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[Sars-Cov-2 positive]
Date of Diagnosis:
Jan/7/2021
3.Toxicity Grade: 2
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001754
Page 39 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001755
Page 40 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001756
Page 41 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001757
Page 42 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001758
Page 43 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001759
Page 44 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001760
Page 45 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Jan/6/2021 Record Identifier: Systolic: Diastolic:
1  104  58 Repeating Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001761
Page 46 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/6/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [104]
Diastolic: [58]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in
beats/minute:[84]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001762
Page 47 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Jan/6/2021 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001763
Page 48 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/6/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001764
Page 49 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001765
Page 50 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001766
Page 51 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001767
Page 52 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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.Start Date: //
6.Ongoing?
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001768
Page 53 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001769
Page 54 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001770
Page 55 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001771
Page 56 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461110 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/3/2021
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 [BR7NFW]
5.bSample ID [BRST0T]
5.cSample ID [BRST0V]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001772
Page 57 of 178
***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: 12461110 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:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001773
Page 58 of 178
***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: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001774
Page 59 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001775
Page 60 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001776
Page 61 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001777
Page 62 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001778
Page 63 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001779
Page 64 of 178
***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: 12461110 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[ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001780
Page 65 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001781
Page 66 of 178
***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: 12461110 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: //
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001782
Page 67 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001783
Page 68 of 178
***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: 12461110 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?
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001784
Page 69 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001785
Page 70 of 178
***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: 12461110 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?
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001786
Page 71 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001787
Page 72 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001788
Page 73 of 178
***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: 12461110 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/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001789
Page 74 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001790
Page 75 of 178
***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: 12461110 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:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001791
Page 76 of 178
***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: 12461110 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?
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001792
Page 77 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001793
Page 78 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001794
Page 79 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001795
Page 80 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001796
Page 81 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001797
Page 82 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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 [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001798
Page 83 of 178
***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: 12461110 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: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001799
Page 84 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001800
Page 85 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001801
Page 86 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001802
Page 87 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001803
Page 88 of 178
***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: 12461110 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: [ ]
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001804
Page 89 of 178
***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: 12461110 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/25/2020
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001805
Page 90 of 178
***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: 12461110 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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001806
Page 91 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany
Musungaie Approved Feb-08-2021 19:18:42 (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.
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001807
Page 92 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-07-2020 16:10:15 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001808
Page 93 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-07-2020 16:18:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001809
Page 94 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany
Musungaie Approved Feb-08-2021 19:18:42 (UTC+02:00)
Harare, PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-08-2021 13:51:33 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-03-2021 21:05:39 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001810
Page 95 of 178
***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: 12461110 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-03-2021 12:44:06 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-27-2021 19:27:48 (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.
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001811
Page 96 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Jan-27-2021 10:02:34 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-08-2021 20:31:17 (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-08-2021 07:29:49 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-07-2021 16:27:43 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001812
Page 97 of 178
***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: 12461110 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-06-2021 13:06:52 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-29-2020 17:24:03 (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.
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001813
Page 98 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Nov-25-2020 09:12:48 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-12-2020 20:30:12 (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.
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001814
Page 99 of 178
***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: 12461110 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-07-2020
16:08:12
(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-07-2020
16:08:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001815
Page 100 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-07-2020
16:09:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/7/2020Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001816
Page 101 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-07-2020
16:09:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-07-2020
16:09:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
12461110Transcription
Error
Oct-07-2020
16:08:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Subject ID is
expected to be
in 8 digits.
Please review.
Oct-07-2020
16:08:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
104534Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-07-2020
16:07:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/2001Enrollment
Entry
3. Sex:
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001817
Page 102 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-07-2020
16:08:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-07-2020
16:08:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-07-2020
16:08:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae302e\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-2021-5683-1001818
Page 103 of 178
***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: 12461110 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-07-2020
16:10:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001819
Page 104 of 178
***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: 12461110 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-07-2020
16:10:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020
16:10:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020
16:10:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001820
Page 105 of 178
***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: 12461110 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-07-2020
16:11:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001821
Page 106 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
90.65Initial Entry
3. Unit:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-07-2020
16:12:00ACV0PFEINFP6000  Data Entry:
184.25Initial Entry
090177e196ae302e\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-2021-5683-1001822
Page 107 of 178
***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: 12461110 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-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.7Initial Entry
7.a
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.8
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001823
Page 108 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-07-2020
16:12:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302e\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-2021-5683-1001824
Page 109 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-07-2020
16:12:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-07-2020
16:12:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
104534Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001825
Page 110 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
16:16:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
16:16:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:17:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
16:16:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001826
Page 111 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-07-2020
16:16:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:17:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9HJBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:17:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9HJBInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020
16:17:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BRSSV
XInitial Entry
090177e196ae302e\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-2021-5683-1001827
Page 112 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Oct-07-2020
16:17:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSSVXInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020
16:17:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BRSSV
YInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020
16:17:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSSVYInitial Entry
090177e196ae302e\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-2021-5683-1001828
Page 113 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
16:17:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
16:17:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:17:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
16:17:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001829
Page 114 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-07-2020
16:17:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:17:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9HJ8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:17:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9HJ8Initial Entry
090177e196ae302e\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-2021-5683-1001830
Page 115 of 178
***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: 12461110 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-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 14:55Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001831
Page 116 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001832
Page 117 of 178
***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: 12461110 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-07-2020
16:13:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001833
Page 118 of 178
***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: 12461110 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-07-2020
16:14:24
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTTranscription
Error
Oct-07-2020
16:13:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001834
Page 119 of 178
***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: 12461110 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-28-2020
09:07:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001835
Page 120 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
2.a
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.3
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae302e\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-2021-5683-1001836
Page 121 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-28-2020
09:08:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302e\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-2021-5683-1001837
Page 122 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
11:03:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
11:03:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
11:04:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
11:03:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001838
Page 123 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-28-2020
11:03:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
11:04:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9DV
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
11:04:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9DVCInitial Entry
090177e196ae302e\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-2021-5683-1001839
Page 124 of 178
***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: 12461110 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-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Oct/28/2020 09:00Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001840
Page 125 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001841
Page 126 of 178
***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: 12461110 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-28-2020
09:33:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001842
Page 127 of 178
***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: 12461110 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-25-2020
09:12:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001843
Page 128 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020
13:52:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020
13:52:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-25-2020
13:53:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-25-2020
13:52:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001844
Page 129 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Nov-25-2020
13:52:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/25/2020Initial Entry
5.a
Date Location User Value Reason
Nov-25-2020
13:53:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9DY
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020
13:53:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9DYNInitial Entry
5.b
Date Location User Value Reason
Nov-25-2020
13:53:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BRYBZ
YInitial Entry
090177e196ae302e\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-2021-5683-1001845
Page 130 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Nov-25-2020
13:53:18
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRYBZYInitial Entry
5.c
Date Location User Value Reason
Nov-25-2020
13:53:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRYBZZInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-25-2020
13:53:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRYBZZInitial Entry
090177e196ae302e\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-2021-5683-1001846
Page 131 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-11-2021
08:16:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Jan-08-2021
07:30:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 3: Answered completed
Jan-08-2021
06:12:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 3: Reissued:
OpenedDM1: Please
verify details
on ILL
POTEN form
is still missing.
Kindly
consider
updating
details. Thank
you.
Jan-07-2021
15:45:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 3: Answered Completed test
results
Jan-07-2021
14:35:08
(UTC+02:00)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001847
Page 132 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria ‘Illness Details
form' at this
visit. Thank
you.
Jan-06-2021
13:09:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-06-2021
13:06:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Jan-06-2021
13:06:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001848
Page 133 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Please review
and update as
appropriate.
Jan-06-2021
13:06:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-06-2021
13:06:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001849
Page 134 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/3/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-27-2021
10:02:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympt
om Resolved:
Jan/27/2021New
Information
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302e\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-2021-5683-1001850
Page 135 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.a
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR IN
CREASEDInitial Entry
090177e196ae302e\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-2021-5683-1001851
Page 136 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria COUGH
Sympto
m Pres
ent:NO
4.b Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATHInitial Entry
090177e196ae302e\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-2021-5683-1001852
Page 137 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Symp
tom P
resent
:NO
4.c Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pre
sent:NOInitial Entry
090177e196ae302e\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-2021-5683-1001853
Page 138 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED M
USCLE PAIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae302e\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-2021-5683-1001854
Page 139 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.e Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE O
R SMELL
Sympt
om Pre
sent:YESInitial Entry
090177e196ae302e\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-2021-5683-1001855
Page 140 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAST
E OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:NOInitial Entry
090177e196ae302e\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-2021-5683-1001856
Page 141 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae302e\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-2021-5683-1001857
Page 142 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae302e\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-2021-5683-1001858
Page 143 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i Symptoms:
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-06-2021
13:07:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001859
Page 144 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001860
Page 145 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME COROInitial Entry
090177e196ae302e\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-2021-5683-1001861
Page 146 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-08-2021
06:19:08
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Jan-07-2021
15:15:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Jan-07-2021
15:15:28ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae302e\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-2021-5683-1001862
Page 147 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
Jan-07-2021
08:28:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Test Result"
is missing.
Kindly
review and
update.
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-06-2021
13:09:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Local lab Ampath ISO
15189 accreditedInitial Entry
090177e196ae302e\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-2021-5683-1001863
Page 148 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021
13:09:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021
13:09:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021
13:09:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jan-06-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001864
Page 149 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13:09:27
(UTC+02:00)
Harare, PretoriaSite visit
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001865
Page 150 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021
13:09:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021
13:09:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021
13:09:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-06-2021
13:09:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001866
Page 151 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Jan-06-2021
13:09:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021
13:09:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9F0GInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021
13:09:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9F0GInitial Entry
090177e196ae302e\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-2021-5683-1001867
Page 152 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:SPEC
IALIS
T
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
090177e196ae302e\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-2021-5683-1001868
Page 153 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:EMERG
ENCY R
OOM
Occurrence
of Visits or
Contacts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:PRIMAR
Y CAREInitial Entry
090177e196ae302e\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-2021-5683-1001869
Page 154 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria PHYSICI
AN
Occurren
ce of Visit
s or Conta
cts:NO
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:URGE
NT CA
REInitial Entry
090177e196ae302e\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-2021-5683-1001870
Page 155 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Occurrence
of Visits or C
ontacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:TELEPH
ONE CO
NSULTA
TION
Occurren
ce of Visit
s or Conta
cts:NOInitial Entry
090177e196ae302e\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-2021-5683-1001871
Page 156 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae302e\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-2021-5683-1001872
Page 157 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-06-2021
13:10:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302e\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-2021-5683-1001873
Page 158 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-08-2021
07:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-08-2021
23:17:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-08-2021
20:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Lab result
received from
lab on 7 Jan
2021 with
result
Jan-08-2021
17:26:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened CLIQUERY:
COVID-19
Date of
Diagnosis is
07Jan2021
however Local
positive
COVID-19 test
date was
090177e196ae302e\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-2021-5683-1001874
Page 159 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
06Jan2021.
Date of
Diagnosis
should match
positive test
date in Local
or Central.
Please update
or clarify.
Jan-08-2021
07:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Respiratory Illnes
s Diagnosis:
Sars-Cov-2 posi
tive
Date of Diagnosis
:
Jan/7/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-08-2021
07:29:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001875
Page 160 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 15-Sep-2020 21:52 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001876
Page 161 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
2.a
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Systolic:: 1
0
4
Diastolic:: 5
8
Respiratory Rate
in respirations/mi
nute:2
0
Heart Rate in bea
ts/minute:8
4Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-06-2021
13:11:38ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae302e\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-2021-5683-1001877
Page 162 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
2.a Systolic:
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
104Initial Entry
2.a Diastolic:
Date Location User Value Reason
Jan-07-2021
11:39:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-06-2021
13:12:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Not clinically
significant
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Diastolic BP
58 is outside
of Normal
Range 60 - 90.
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
58Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001878
Page 163 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
20Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Jan-06-2021
13:11:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
84Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001879
Page 164 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit
Trail
Form Version: 15-Sep-2020 21:54 Form Status:
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-06-2021
13:12:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001880
Page 165 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Jan-06-2021
13:12:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
2.a
Date Location User Value Reason
Jan-06-2021
13:12:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Oxygen Saturati
on:98.
0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-06-2021
13:12:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Jan-06-2021
13:12:43ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
090177e196ae302e\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-2021-5683-1001881
Page 166 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001882
Page 167 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461110 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-03-2021
12:44:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-03-2021
12:44:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001883
Page 168 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021
12:44:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
12:44:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
12:44:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
12:44:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001884
Page 169 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Feb-03-2021
12:44:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
12:44:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BR7NF
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
12:44:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BR7NFWInitial Entry
5.b
Date Location User Value Reason
Feb-03-2021
12:44:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRST0TInitial Entry
090177e196ae302e\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-2021-5683-1001885
Page 170 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Feb-03-2021
12:44:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRST0TInitial Entry
5.c
Date Location User Value Reason
Feb-03-2021
12:44:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRST0VInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-03-2021
12:44:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRST0VInitial Entry
090177e196ae302e\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-2021-5683-1001886
Page 171 of 178
***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: 12461110 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-25-2020
09:13:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-25-2020
09:13:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-25-2020
09:13:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001887
Page 172 of 178
***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: 12461110 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
13:51:33
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001888
Page 173 of 178
***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: 12461110 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
13:51:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-08-2021
13:51:44
(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
13:51:44
(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
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001889
Page 174 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
t Vaccination 1/2
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001890
Page 175 of 178
***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: 12461110 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
13:51:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-08-2021
13:51:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001891
Page 176 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-25-2020
09:13:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-07-2020
16:12:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-07-2020
16:10:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-25-2020
09:13:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/25/2020Initial Entry
Oct-07-2020
16:12:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Oct-07-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001892
Page 177 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
16:10:31
(UTC+02:00)
Harare, Pretoria(autocalc) Oct/7/2020
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001893
Page 178 of 178
***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: 12461110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-12-2020
13:16:07
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae302e\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001894