125742 S1 M5 CRF c4591001 1246 12461070

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
331
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001386
Page 2 of 331
***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: 12461070 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/3/2020
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001387
Page 3 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12461070]
2.Birth Date: UNK/UNK/1998
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001388
Page 4 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/3/2020
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001389
Page 5 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001390
Page 6 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001391
Page 7 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Obese]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001392
Page 8 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001393
Page 9 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/3/2020
2.Weight: [113.0]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [38.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001394
Page 10 of 331
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/3/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001395
Page 11 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/3/2020
2.Randomization Number: [103401]
3.Randomization Group: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001396
Page 12 of 331
***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: 12461070 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/3/2020
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 [BM9HGH]
5.bSample ID [BRSSSH]
5.cSample ID [BRSSSJ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001397
Page 13 of 331
***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: 12461070 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/3/2020
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 [BM9HGB]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001398
Page 14 of 331
***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: 12461070 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/3/2020 10:20
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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001399
Page 15 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001400
Page 16 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/24/2020
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001401
Page 17 of 331
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001402
Page 18 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001403
Page 19 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001404
Page 20 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001405
Page 21 of 331
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/24/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001406
Page 22 of 331
***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: 12461070 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/24/2020
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 [BM9HNL]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001407
Page 23 of 331
***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: 12461070 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/24/2020 08:20
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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001408
Page 24 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/21/2020
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001409
Page 25 of 331
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001410
Page 26 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001411
Page 27 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001412
Page 28 of 331
***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: 12461070 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/21/2020
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 [BM9DXT]
5.bSample ID [BRYBY7]
5.cSample ID [BRYBY6]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001413
Page 29 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001414
Page 30 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001415
Page 31 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001416
Page 32 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001417
Page 33 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001418
Page 34 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001419
Page 35 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001420
Page 36 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/19/2021
2.Date of First Symptom
Started:Jan/18/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/19/2021
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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001421
Page 37 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [Nausea]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001422
Page 38 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001423
Page 39 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001424
Page 40 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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:[Not done, don't want to selfswab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001425
Page 41 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Patient can't attend site due to work circumstances.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001426
Page 42 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001427
Page 43 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001428
Page 44 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001429
Page 45 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001430
Page 46 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
[gastritis]
Date of Diagnosis:
Jan/19/2021
3.Toxicity Grade: 1
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001431
Page 47 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001432
Page 48 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001433
Page 49 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001434
Page 50 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001435
Page 51 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001436
Page 52 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001437
Page 53 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001438
Page 54 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in
beats/minute:Not Done
[ ]Comments
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001439
Page 55 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001440
Page 56 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001441
Page 57 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001442
Page 58 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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):[ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001443
Page 59 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001444
Page 60 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001445
Page 61 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001446
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001447
Page 63 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 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_B
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001448
Page 64 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/3/2021
2.Date of First Symptom
Started:Feb/1/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/3/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001449
Page 65 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001450
Page 66 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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.Feb/3/2
021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001451
Page 67 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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: Feb/3/2021
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: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ISO 15189 accredited lab]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001452
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 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:[sample done at site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001453
Page 69 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/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 [BM9F0S]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001454
Page 70 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001455
Page 71 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001456
Page 72 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001457
Page 73 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001458
Page 74 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
[bronchitis]
Date of Diagnosis:
Feb/4/2021
3.Toxicity Grade: 2
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001459
Page 75 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001460
Page 76 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001461
Page 77 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001462
Page 78 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001463
Page 79 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001464
Page 80 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001465
Page 81 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Feb/3/2021 Record Identifier: Systolic: Diastolic:
1  120  87 Repeating Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001466
Page 82 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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: Feb/3/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [87]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in
beats/minute:[94]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001467
Page 83 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1.Feb/3/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001468
Page 84 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: 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: 12461070 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: Feb/3/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001469
Page 85 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001470
Page 86 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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):[ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001471
Page 87 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001472
Page 88 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001473
Page 89 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001474
Page 90 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/03/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001475
Page 91 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001476
Page 92 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: 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: 12461070 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/15/2021
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 [BR7N54]
5.bSample ID [BRST30]
5.cSample ID [BRST31]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001477
Page 93 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001478
Page 94 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/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: 12461070 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:
Mar/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 [BM9F2V]
5.bSample ID [BRST4C]
5.cSample ID [BRST4D]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001479
Page 95 of 331
***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: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001480
Page 96 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001481
Page 97 of 331
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001482
Page 98 of 331
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/28/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001483
Page 99 of 331
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/28/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/28/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN
E-DIARY
3.Comments: [Did not complete, child was at hospital last night. She has no
symptoms.]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001484
Page 100 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
 1.ADVERS
E EVENT
 1  Urine tract Infectio
n-pathogen unknow
n Nov/15/202
0 UNK:UN
K NO
End Date Time:
Nov/18/2020 U
NK:UNK
 Repeating
Pages
 2.ADVERS
E EVENT
 2  Worsening of depre
ssion Dec/25/2020
UNK:UNK NO
End Date Time:
Jan/15/2021 UN
K:UNK
 Repeating
Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001485
Page 101 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Urine tract Infection-pathogen unknown]
4.Start Date Time: Nov/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/18/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001486
Page 102 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001487
Page 103 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001488
Page 104 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Worsening of depression]
4.Start Date Time: Dec/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001489
Page 105 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Medical history Depression- stopped conmeds]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001490
Page 106 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021039621]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001491
Page 107 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001492
Page 108 of 331
***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: 12461070 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[ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001493
Page 109 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001494
Page 110 of 331
***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: 12461070 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: //
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001495
Page 111 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001496
Page 112 of 331
***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: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001497
Page 113 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001498
Page 114 of 331
***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: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001499
Page 115 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001500
Page 116 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001501
Page 117 of 331
***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: 12461070 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001502
Page 118 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001503
Page 119 of 331
***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: 12461070 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:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001504
Page 120 of 331
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001505
Page 121 of 331
***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: 12461070 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?
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001506
Page 122 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001507
Page 123 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001508
Page 124 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001509
Page 125 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001510
Page 126 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001511
Page 127 of 331
***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: 12461070 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 [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001512
Page 128 of 331
***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: 12461070 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: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001513
Page 129 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001514
Page 130 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001515
Page 131 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001516
Page 132 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001517
Page 133 of 331
***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: 12461070 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: [ ]
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001518
Page 134 of 331
***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: 12461070 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/21/2020
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001519
Page 135 of 331
***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: 12461070 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
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001520
Page 136 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany
Musungaie Approved Mar-03-2021 19:35:32 (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.
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001521
Page 137 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-03-2020 11:38:30 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001522
Page 138 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormJan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001523
Page 139 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001524
Page 140 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001525
Page 141 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001526
Page 142 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001527
Page 143 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001528
Page 144 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001529
Page 145 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
7Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001530
Page 146 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
8Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001531
Page 147 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
9Jan-25-2021 11:30:45 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001532
Page 148 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormJan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001533
Page 149 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Jan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001534
Page 150 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aJan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001535
Page 151 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aJan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001536
Page 152 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aJan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001537
Page 153 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aJan-25-2021 11:34:11 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001538
Page 154 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormJan-25-2021 11:34:31 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001539
Page 155 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Jan-25-2021 11:34:31 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001540
Page 156 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aJan-25-2021 11:34:31 (UTC+02:00)
Harare, PretoriaPatient can't attend site due to work
circumstances.
Not Done
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(
 
 
 
(b) (4)
FDA-CBER-2021-5683-1001541
Page 157 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Dany
Musungaie Approved Mar-03-2021 19:35:32 (UTC+02:00)
Harare, PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-03-2021 08:15:11 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-15-2021 18:18:34 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001542
Page 158 of 331
***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: 12461070 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-15-2021 10:48:01 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-05-2021 18:31:54 (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.
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001543
Page 159 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Feb-05-2021 10:57:04 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-04-2021 19:39:08 (UTC+02:00)
Harare, PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-04-2021 07:48:02 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-03-2021 21:02:31 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001544
Page 160 of 331
***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: 12461070 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 11:36:22 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-25-2021 19:33:34 (UTC+02:00)
Harare, PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001545
Page 161 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Jan-25-2021 11:27:13 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-20-2021 16:13:33 (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-20-2021 14:20:11 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-18-2021 19:56:17 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001546
Page 162 of 331
***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: 12461070 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-18-2021 14:20:26 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Dec-10-2020 19:21:30 (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.
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001547
Page 163 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Dec-09-2020 15:54:40 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-27-2020 07:26:03 (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.
 N/A Nov-21-2020 08:52:33 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-12-2020 20:05:29 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001548
Page 164 of 331
***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: 12461070 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.
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001549
Page 165 of 331
***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: 12461070 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-03-2020
11:36:37
(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-03-2020
11:36:37
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001550
Page 166 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-03-2020
11:36:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/3/2020Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001551
Page 167 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-03-2020
11:36:23
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12461070Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-03-2020
11:36:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1998Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-03-2020
11:37:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-03-2020
11:37:17
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SPInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001552
Page 168 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria ANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-03-2020
11:37:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001553
Page 169 of 331
***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: 12461070 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-03-2020
11:38:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001554
Page 170 of 331
***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: 12461070 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-03-2020
11:38:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-03-2020
11:38:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-03-2020
11:38:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001555
Page 171 of 331
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-03-2020
11:39:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Depressi
on
Start Date: UNK/U
NK/201
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-03-2020
11:39:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-03-2020
11:39:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001556
Page 172 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.a Start Date:
Date Location User Value Reason
Oct-03-2020
11:39:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-03-2020
11:39:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-03-2020
11:43:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Obese
Start Date: UNK/U
NK/201
4
Ongoing: YESInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001557
Page 173 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-03-2020
11:43:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-03-2020
11:43:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ObeseInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-03-2020
11:43:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-03-2020
11:43:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302d\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-2021-5683-1001558
Page 174 of 331
***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: 12461070 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-03-2020
11:39:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
The subject is NOT kn
own to be HIV POSITI
VEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001559
Page 175 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
113.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-03-2020
11:41:17ACV0PFEINFP6000  Data Entry:
172.0Initial Entry
090177e196ae302d\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-2021-5683-1001560
Page 176 of 331
***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: 12461070 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-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.2Initial Entry
7.a
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
090177e196ae302d\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-2021-5683-1001561
Page 177 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-03-2020
11:41:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302d\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-2021-5683-1001562
Page 178 of 331
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-03-2020
11:43:47ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001563
Page 179 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Specimen Type:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-03-2020
11:43:47ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001564
Page 180 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
6.a Test:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-03-2020
11:43:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001565
Page 181 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-03-2020
11:45:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-03-2020
11:45:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
103401Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001566
Page 182 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-03-2020
11:45:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-03-2020
11:45:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-03-2020
11:48:24
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-03-2020
11:45:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001567
Page 183 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-03-2020
11:45:14
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/3/2020Initial Entry
5.a
Date Location User Value Reason
Oct-03-2020
11:48:24
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9HG
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-03-2020
11:48:24
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9HGHInitial Entry
5.b
Date Location User Value Reason
Oct-03-2020
11:49:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSSSHInitial Entry
090177e196ae302d\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-2021-5683-1001568
Page 184 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Oct-03-2020
11:49:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSSSHInitial Entry
5.c
Date Location User Value Reason
Oct-03-2020
11:49:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSSSJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-03-2020
11:49:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSSSJInitial Entry
090177e196ae302d\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-2021-5683-1001569
Page 185 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-03-2020
11:50:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-03-2020
11:50:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-03-2020
11:50:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-03-2020
11:50:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001570
Page 186 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-03-2020
11:50:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/3/2020Initial Entry
5.a
Date Location User Value Reason
Oct-03-2020
11:50:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9HG
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-03-2020
11:50:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9HGBInitial Entry
090177e196ae302d\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-2021-5683-1001571
Page 187 of 331
***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: 12461070 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-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Oct/3/2020 10:20Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001572
Page 188 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001573
Page 189 of 331
***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: 12461070 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-03-2020
11:51:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001574
Page 190 of 331
***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: 12461070 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-03-2020
11:51:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001575
Page 191 of 331
***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: 12461070 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-24-2020
09:18:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001576
Page 192 of 331
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001577
Page 193 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae302d\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-2021-5683-1001578
Page 194 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae302d\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-2021-5683-1001579
Page 195 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
LInitial Entry
090177e196ae302d\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-2021-5683-1001580
Page 196 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.d Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-24-2020
09:19:19ACV0PFEINFP6000  Data Entry:
Symptom:: VOInitial Entry
090177e196ae302d\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-2021-5683-1001581
Page 197 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, PretoriaMI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:NO
2.e Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae302d\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-2021-5683-1001582
Page 198 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
090177e196ae302d\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-2021-5683-1001583
Page 199 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001584
Page 200 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae302d\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-2021-5683-1001585
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.h Symptom:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001586
Page 202 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
4. Injection Site Body Side:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-24-2020
09:19:19ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae302d\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-2021-5683-1001587
Page 203 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae302d\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-2021-5683-1001588
Page 204 of 331
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae302d\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-2021-5683-1001589
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-24-2020
09:19:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001590
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***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
2.a
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae302d\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-2021-5683-1001591
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***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-24-2020
09:19:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302d\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-2021-5683-1001592
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***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-24-2020
09:20:13ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001593
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Specimen Type:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-24-2020
09:20:13ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001594
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
6.a Test:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-24-2020
09:20:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001595
Page 211 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-24-2020
09:20:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020
09:20:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-24-2020
09:22:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-24-2020
09:20:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001596
Page 212 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-24-2020
09:20:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/24/2020Initial Entry
5.a
Date Location User Value Reason
Oct-24-2020
09:22:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample I
D:BM9HN
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-24-2020
09:22:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9HNLInitial Entry
090177e196ae302d\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-2021-5683-1001597
Page 213 of 331
***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: 12461070 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-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Oct/24/2020 08:20Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001598
Page 214 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1001599
Page 215 of 331
***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: 12461070 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-24-2020
09:23:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001600
Page 216 of 331
***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: 12461070 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-21-2020
08:52:33
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/21/2020Initial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001601
Page 217 of 331
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001602
Page 218 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae302d\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-2021-5683-1001603
Page 219 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae302d\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-2021-5683-1001604
Page 220 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
LInitial Entry
090177e196ae302d\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-2021-5683-1001605
Page 221 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.d Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-21-2020
08:53:00ACV0PFEINFP6000  Data Entry:
Symptom:: VOInitial Entry
090177e196ae302d\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-2021-5683-1001606
Page 222 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, PretoriaMI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:NO
2.e Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae302d\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-2021-5683-1001607
Page 223 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
2.f Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
090177e196ae302d\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-2021-5683-1001608
Page 224 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001609
Page 225 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae302d\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-2021-5683-1001610
Page 226 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.h Symptom:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001611
Page 227 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Harare, Pretoria
4. Injection Site Body Side:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-21-2020
08:53:00ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae302d\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-2021-5683-1001612
Page 228 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae302d\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-2021-5683-1001613
Page 229 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae302d\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-2021-5683-1001614
Page 230 of 331
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-21-2020
08:53:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001615
Page 231 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-21-2020
08:53:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-21-2020
08:53:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-21-2020
08:53:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-21-2020
08:53:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001616
Page 232 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Nov-21-2020
08:53:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/21/2020Initial Entry
5.a
Date Location User Value Reason
Nov-21-2020
08:53:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample I
D:BM9DX
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-21-2020
08:53:32
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9DXTInitial Entry
5.b
Date Location User Value Reason
Dec-09-2020
15:54:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BRYBY7Initial Entry
090177e196ae302d\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-2021-5683-1001617
Page 233 of 331
***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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Dec-09-2020
15:54:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRYBY7Initial Entry
5.c
Date Location User Value Reason
Dec-09-2020
15:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BRYBY6Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-09-2020
15:54:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRYBY6Initial Entry
090177e196ae302d\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-2021-5683-1001618
Page 234 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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-25-2021
18:16:22
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Deleted Query is
invalid or does
not apply
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-25-2021
11:27:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eDate of Visit
is completed
but Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Jan-25-2021
11:27:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eDate of Visit
is completed
but Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001619
Page 235 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
are missing.
Please review
and update as
appropriate.
Jan-25-2021
11:27:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-25-2021
11:27:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001620
Page 236 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 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-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympto
m Resolved:
Jan/19/2021Initial Entry
4.a
Date Location User Value Reason
090177e196ae302d\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-2021-5683-1001621
Page 237 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR IN
CREASED
COUGHInitial Entry
090177e196ae302d\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-2021-5683-1001622
Page 238 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sympto
m Pres
ent:NO
4.b Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATH
Symp
tom P
resent
:NOInitial Entry
090177e196ae302d\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-2021-5683-1001623
Page 239 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.c Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(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-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pre
sent:NOInitial Entry
090177e196ae302d\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-2021-5683-1001624
Page 240 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED M
USCLE PAIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae302d\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-2021-5683-1001625
Page 241 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.e Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(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-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE O
R SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae302d\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-2021-5683-1001626
Page 242 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(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-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:NOInitial Entry
090177e196ae302d\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-2021-5683-1001627
Page 243 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(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-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae302d\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-2021-5683-1001628
Page 244 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:YESInitial Entry
090177e196ae302d\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-2021-5683-1001629
Page 245 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i Symptoms:
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-25-2021
11:27:53
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Jan-25-2021
11:28:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptoms - O
ther:Naus
eaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-25-2021
11:28:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
090177e196ae302d\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-2021-5683-1001630
Page 246 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 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-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-25-2021
11:30:45ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae302d\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-2021-5683-1001631
Page 247 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/19/2021Form: 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: 12461070 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC+02:00)
Harare, Pretoria
5. Device Type:
Date Location User Value Reason
Jan-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-25-2021
11:30:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-25-2021
11:30:45ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae302d\Final\Final On: 01-Apr-2021 04:02 (
…[truncated]
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