125742 S1 M5 CRF c4591001 1246 12461025

Document text

Page 1 of 360
***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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000861
Page 2 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/28/2020
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000862
Page 3 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12461025]
2.Birth Date: UNK/UNK/1975
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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000863
Page 4 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000864
Page 5 of 360
***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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000865
Page 6 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000866
Page 7 of 360
***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: 12461025 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:[Asthma]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000867
Page 8 of 360
***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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000868
Page 9 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
2.Weight: [62.0]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [21.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000869
Page 10 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000870
Page 11 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/28/2020
2.Randomization Number: [101166]
3.Randomization Group: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000871
Page 12 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9HCX]
5.bSample ID [BRSSNS]
5.cSample ID [BRSSNT]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000872
Page 13 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9HCH]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000873
Page 14 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/28/2020 10:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000874
Page 15 of 360
***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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000875
Page 16 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000876
Page 17 of 360
***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: 12461025 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?YES
Ongoing?
YES
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
YES
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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000877
Page 18 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000878
Page 19 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000879
Page 20 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000880
Page 21 of 360
***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: 12461025 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/19/2020
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 [BM9HM1]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000881
Page 22 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000882
Page 23 of 360
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000883
Page 24 of 360
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000884
Page 25 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000885
Page 26 of 360
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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/16/2020
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 [BM9F44]
5.bSample ID [BRSSZF]
5.cSample ID [BRSSZG]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000886
Page 27 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000887
Page 28 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000888
Page 29 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000889
Page 30 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000890
Page 31 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000891
Page 32 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000892
Page 33 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000893
Page 34 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/2/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/6/2020
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000894
Page 35 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.Symptoms - Other Text: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000895
Page 36 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/2/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000896
Page 37 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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: Nov/2/2020
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: [Local Ampath lab]
9.Trade Name Other, Specify: [SARS COV-2 test ISO 15189 accredited lab]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000897
Page 38 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Swab done at site] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000898
Page 39 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: 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: 12461025 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:
Nov/2/2020
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 [CV55741]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000899
Page 40 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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
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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000900
Page 41 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000901
Page 42 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000902
Page 43 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
[Common cold]
Date of Diagnosis:
Nov/3/2020
3.Toxicity Grade: 2
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000903
Page 44 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000904
Page 45 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000905
Page 46 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000906
Page 47 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: 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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000907
Page 48 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000908
Page 49 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: 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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000909
Page 50 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1.Nov/2/2020 Record Identifier: Systolic: Diastolic:
1  119  82 Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000910
Page 51 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [119]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [88]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000911
Page 52 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1.Nov/2/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000912
Page 53 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000913
Page 54 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000914
Page 55 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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): [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000915
Page 56 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000916
Page 57 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000917
Page 58 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000918
Page 59 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000919
Page 60 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000920
Page 61 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/5/2021
2.Date of First Symptom Started: Dec/31/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/26/2021
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000921
Page 62 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.Symptoms - Other Text: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000922
Page 63 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/5/2021
 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000923
Page 64 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/5/2021
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: [Ampath local lab ISO 15189 accredited]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000924
Page 65 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 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:[Came to site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000925
Page 66 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
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 [BM9F0C]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000926
Page 67 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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: YES
Number of Visits or Contacts:
[1]
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
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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000927
Page 68 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000928
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000929
Page 70 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
[Common cold]
Date of Diagnosis:
Jan/7/2021
3.Toxicity Grade: 2
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000930
Page 71 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000931
Page 72 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000932
Page 73 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000933
Page 74 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000934
Page 75 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000935
Page 76 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000936
Page 77 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1.Jan/5/2021 Record Identifier: Systolic: Diastolic:
1  113  79 Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000937
Page 78 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/5/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [113]
Diastolic: [79]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [95]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000938
Page 79 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1.Jan/5/2021 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000939
Page 80 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/5/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000940
Page 81 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000941
Page 82 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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): [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000942
Page 83 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000943
Page 84 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000944
Page 85 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000945
Page 86 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/05/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000946
Page 87 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000947
Page 88 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: 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: 12461025 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/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9F01]
5.bSample ID [BRYC2N]
5.cSample ID [BRYC2P]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000948
Page 89 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/02/2021Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000949
Page 90 of 360
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/02/2021Form: 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: 12461025 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/2/2021
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 [BM9F0P]
5.bSample ID [BRST0N]
5.cSample ID [BRST0P]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000950
Page 91 of 360
***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: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000951
Page 92 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000952
Page 93 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000953
Page 94 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000954
Page 95 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: 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: 12461025 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:
Sep/29/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000955
Page 96 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000956
Page 97 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Sep/29/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: YES
Maximum Diameter (cm):
[0.25]
Minimum Diameter (cm):
[0.25]
Meets Grade 4 Reaction Criteria:
NO
4.bReaction: SWELLING
Reaction Present: YES
Maximum Diameter (cm):
[0.25]
Minimum Diameter (cm):
[0.25]
Meets Grade 4 Reaction Criteria:
NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000957
Page 98 of 360
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.cSymptom: HEADACHE
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000958
Page 99 of 360
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.hSymptom: CHILLS
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000959
Page 100 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000960
Page 101 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000961
Page 102 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: 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: 12461025 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/2/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000962
Page 103 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/03/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000963
Page 104 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/03/2020Form: 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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000964
Page 105 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/03/2020Form: 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: 12461025 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:
Nov/3/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Covid results provided to patient]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000965
Page 106 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  urticaria generalized  Sep/29/2020 00:0
1 NO
End Date Time:
Oct/2/2020 18:15
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Intermittent urticaria gen
eralised. Oct/7/2020 UNK:
UNK NO
End Date Time:
Nov/2/2020 UNK:UNK
 Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000966
Page 107 of 360
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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)[urticaria generalized]
4.Start Date Time: Sep/29/2020 00:01
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 18:15
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000967
Page 108 of 360
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000968
Page 109 of 360
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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)[Intermittent urticaria generalised.]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000969
Page 110 of 360
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000970
Page 111 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000971
Page 112 of 360
***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: 12461025 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[ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000972
Page 113 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000973
Page 114 of 360
***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: 12461025 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: //
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000974
Page 115 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000975
Page 116 of 360
***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: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000976
Page 117 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000977
Page 118 of 360
***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: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000978
Page 119 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000979
Page 120 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000980
Page 121 of 360
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000981
Page 122 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000982
Page 123 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000983
Page 124 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000984
Page 125 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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?
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000985
Page 126 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000986
Page 127 of 360
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000987
Page 128 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000988
Page 129 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000989
Page 130 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000990
Page 131 of 360
***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: 12461025 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 [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000991
Page 132 of 360
***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: 12461025 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: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000992
Page 133 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000993
Page 134 of 360
***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, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000994
Page 135 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000995
Page 136 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000996
Page 137 of 360
***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: 12461025 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: [ ]
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000997
Page 138 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/19/2020
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000998
Page 139 of 360
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000999
Page 140 of 360
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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 19:31:46 (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.
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-1001000
Page 141 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormSep-30-2020 15:04:16 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001001
Page 142 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormSep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001002
Page 143 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Sep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001003
Page 144 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Sep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001004
Page 145 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Sep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001005
Page 146 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Sep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001006
Page 147 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Sep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001007
Page 148 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aSep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001008
Page 149 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aSep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001009
Page 150 of 360
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aSep-30-2020 15:04:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001010
Page 151 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001011
Page 152 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001012
Page 153 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001013
Page 154 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001014
Page 155 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001015
Page 156 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001016
Page 157 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001017
Page 158 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001018
Page 159 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-19-2020 11:29:58 (UTC+02:00) Harare,
PretoriaHysteryctomy
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001019
Page 160 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001020
Page 161 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001021
Page 162 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001022
Page 163 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001023
Page 164 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001024
Page 165 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001025
Page 166 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001026
Page 167 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
7Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001027
Page 168 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
8Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001028
Page 169 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
9Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001029
Page 170 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
10Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001030
Page 171 of 360
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
11Oct-19-2020 11:30:51 (UTC+02:00) Harare,
PretoriaInvestigator decision not to vaccinate today
Not Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001031
Page 172 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormNov-17-2020 11:41:47 (UTC+02:00) Harare,
PretoriaSubject did not have Vaccine 2
FormNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
FormNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\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-2021-5683-1001032
Page 173 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Nov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
1Nov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001033
Page 174 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.aNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.aNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001034
Page 175 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.bNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.bNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001035
Page 176 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.cNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.cNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001036
Page 177 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.dNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.dNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001037
Page 178 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.eNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.eNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001038
Page 179 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2 fNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2 fNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001039
Page 180 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2.gNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2.gNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001040
Page 181 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2 hNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
2 hNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001041
Page 182 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Nov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
3Nov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001042
Page 183 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Nov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
4Nov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001043
Page 184 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.aNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
5.aNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001044
Page 185 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.bNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
5.bNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001045
Page 186 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.cNov-16-2020 09:59:21 (UTC+02:00) Harare,
PretoriaNot Applicable
5.cNov-16-2020 09:57:57 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001046
Page 187 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormNov-04-2020 10:28:44 (UTC+02:00) Harare,
Pretoria
FormNov-02-2020 11:35:26 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001047
Page 188 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Nov-04-2020 10:28:44 (UTC+02:00) Harare,
Pretoria
1Nov-02-2020 11:35:26 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001048
Page 189 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Nov-04-2020 10:28:44 (UTC+02:00) Harare,
Pretoria
2Nov-02-2020 11:35:26 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001049
Page 190 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Nov-04-2020 10:28:44 (UTC+02:00) Harare,
Pretoria
3Nov-02-2020 11:35:26 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001050
Page 191 of 360
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Nov-04-2020 10:28:44 (UTC+02:00) Harare,
Pretoria
4Nov-02-2020 11:35:26 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001051
Page 192 of 360
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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 19:31:46 (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 07:25:43 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-08-2021 19:10:27 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-08-2021 13:06:56 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-04-2021 19:09:31 (UTC+02:00) Harare,
PretoriaBOOK Signed
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001052
Page 193 of 360
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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-04-2021 10:51:34 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Feb-02-2021 18:46:41 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-02-2021 09:21:17 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Jan-07-2021 16:25:48 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001053
Page 194 of 360
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Jan-05-2021 11:56:17 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-30-2020 13:57:47 (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-30-2020 10:11:40 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-17-2020 19:33:46 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, DanyMusungaie, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 11:41:47 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-16-2020 18:50:05 (UTC+02:00) Harare,
PretoriaBOOK Signed
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001054
Page 195 of 360
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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 Nov-16-2020 09:56:56 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Dany
Musungaie Approved Nov-12-2020 18:26:43 (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.
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001055
Page 196 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020 16:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020 16:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001056
Page 197 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020 16:24:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/28/2020Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001057
Page 198 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020 16:24:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12461025Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-28-2020 16:24:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020 16:25:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020 16:25:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020 16:25:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae302f\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-2021-5683-1001058
Page 199 of 360
***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: 12461025 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-01-2020 08:33:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 15:04:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Completed
Sep-30-2020 08:13:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened DM Query: Kindly
review and complete
‘pregnancy form' at
this visit. If test ‘Not
done’, Please add
Form level comment
“Not Applicable”.
Thank you.
Sep-28-2020 16:25:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae302f\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-2021-5683-1001059
Page 200 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020 16:26:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 16:26:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 16:26:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001060
Page 201 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 16:41:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Asthma
Start Date: UNK/UNK/201
5
Ongoing: NO
End Date:
UNK/UNK/2
015Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020 16:41:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 16:41:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-28-2020 16:41:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020 16:41:04
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302f\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-2021-5683-1001061
Page 202 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria End Date:
UNK/UNK/2015
1.b
Date Location User Value Reason
Sep-28-2020 16:42:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hysterectomy
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/1
998Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001062
Page 203 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-28-2020 16:42:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 16:42:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
HysterectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-28-2020 16:42:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-28-2020 16:42:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae302f\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-2021-5683-1001063
Page 204 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-28-2020 16:42:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001064
Page 205 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
62.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.0Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001065
Page 206 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001066
Page 207 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Iden
tifier:Not Applica
bleInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001067
Page 208 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-30-2020 15:04:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae302f\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-2021-5683-1001068
Page 209 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020 16:45:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020 16:45:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
101166Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001069
Page 210 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 16:46:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 16:46:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 16:54:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 16:53:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Changed Information
Sep-28-2020 16:46:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-28-2020 16:46:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020 16:54:08
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Sample ID: BM9HCXInitial Entry
090177e196ae302f\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-2021-5683-1001070
Page 211 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 16:54:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9HCXInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 16:54:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSSNSInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 16:54:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSSNSInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 16:54:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSSNTInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 16:54:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSSNTInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1001071
Page 212 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 16:46:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 16:46:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 16:55:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 16:46:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-28-2020 16:46:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 16:55:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9HCHInitial Entry
5.a Sample ID
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001072
Page 213 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-28-2020 16:55:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9HCHInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001073
Page 214 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020 10:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae302f\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-2021-5683-1001074
Page 215 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7. Route:
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 16:47:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001075
Page 216 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020 16:47:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001076
Page 217 of 360
***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: 12461025 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-19-2020 11:28:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001077
Page 218 of 360
***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: 12461025 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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FATI
GUEInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001078
Page 219 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:YES
Ong
oing
?
YE
S
2.b Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESInitial Entry
2.c
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEAD
ACHE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:YES
Ongo
ing?
YE
SInitial Entry
090177e196ae302f\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-2021-5683-1001079
Page 220 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESInitial Entry
2.d
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001080
Page 221 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae302f\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-2021-5683-1001081
Page 222 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001082
Page 223 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
090177e196ae302f\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-2021-5683-1001083
Page 224 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
090177e196ae302f\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-2021-5683-1001084
Page 225 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-19-2020 11:29:10
(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-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-19-2020 11:29:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001085
Page 226 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2.a
Date Location User Value Reason
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.1
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001086
Page 227 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-19-2020 11:29:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001087
Page 228 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identif
ier:Not Don
eInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001088
Page 229 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Test:: Not Don
e
Result:: Not Don
e
Not Done:: Not Don
e
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-19-2020 11:29:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae302f\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-2021-5683-1001089
Page 230 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 11:28:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 11:28:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 11:29:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 11:28:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-19-2020 11:28:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 11:29:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9HM1Initial Entry
5.a Sample ID
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001090
Page 231 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-19-2020 11:29:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9HM1Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001091
Page 232 of 360
***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: 12461025 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-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 21:16:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Closed Site noted on AE log
that AE of
intermittent urticaria
resulted in
discontinuation of
study treatment
Oct-19-2020 18:43:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Opened CLINQUERY: Visit
#2 occurred on 19Oct
however no data are
entered for
vaccination #2.
Please clarify if dose
was temporarily
delayed due to
ongoing fatigue and
headache or if
decision was made to
discontinue
treatment. Thank
you.
Oct-19-2020 18:42:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed will send revised
query
Oct-19-2020 18:06:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened CLINQUERY: Visit
#2 occurred on 19Oct
however no data are
entered for
vaccination #2.
Please clarify if dose
was temporarily
delayed due to
ongoing fatigue and
headache. Thank you.
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1001092
Page 233 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001093
Page 234 of 360
***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: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9. Unit:
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-19-2020 11:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae302f\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-2021-5683-1001094
Page 235 of 360
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 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-16-2020 09:56:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001095
Page 236 of 360
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-17-2020
17:03:40
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
ClosedResponse satisfies
query
Nov-17-2020
11:42:38
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
AnsweredSubject did not have
Vaccine 2, vaccine
diary not applicable.
Nov-17-2020
10:57:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW5386852;Were
medications to treat
fever/pain
given on the last day
the Subject
Diary was
completed? is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1001096
Page 237 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-16-2020 09:59:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:42:49
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:28:55
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386816;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001097
Page 238 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.b
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
090177e196ae302f\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-2021-5683-1001098
Page 239 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:43:01
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:34:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386817;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.c
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NotInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001099
Page 240 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
e
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001100
Page 241 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:43:13
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:34:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386818;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.d
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NotInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001101
Page 242 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
e
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1001102
Page 243 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.d Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:43:24
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:34:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386819;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.e
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NotInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001103
Page 244 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
e
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001104
Page 245 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:43:35
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:34:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386820;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.f
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NotInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1001105
Page 246 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Pretoria Done
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
e
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Do
neInitial Entry
090177e196ae302f\Final\Final On: 01-Apr-2021 04:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1001106
Page 247 of 360
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1246 Site Name: (1246) Jongaie Research
Subject No: 12461025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Symptom:
Date Location User Value Reason
Nov-16-2020 09:57:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-17-2020
17:04:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-17-2020
11:43:45
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredSubject did not have
Vaccine 2, vaccine diary
not applicable.
Nov-17-2020
11:34:31
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5386821;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-16-2020
09:59:21
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
09:57:57
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
2.g
Date Location User Value Reason
Nov-16-2020 09:59:21
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NotInitial Entry
090177e196ae30
…[truncated]