125742 S1 M5 CRF c4591001 1230 12301045

Document text

Page 1 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829492
Page 2 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/28/2020
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829493
Page 3 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12301045]
2.Birth Date: UNK/UNK/1993
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829494
Page 4 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829495
Page 5 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829496
Page 6 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829497
Page 7 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIV]
Start Date: Sep/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[C-Section]
Start Date: Oct/8/2015
Ongoing: NO
End Date:
Oct/8/2015
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Preeclampsia]
Start Date: Oct/8/2015
Ongoing: NO
End Date:
Oct/8/2015
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829498
Page 8 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is known to be HIV POSITIVE
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829499
Page 9 of 229
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [National Health Laboratory Service, Thabazimbi Hospital, 10 First Avenue,
Thabazimbi, Limpopo, South Africa]
3.Collection Date: Jul/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [2124]
Test: HIV RNA (Ultrasensitive)
Result: [<20]
LNMT Low
[20]
High
[10000000]
Unit
/mL
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829500
Page 10 of 229
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Lacet Thabazimbi, Carpediem Medical Centre, 13th Avenue, Thabazimbi, Limpop,
South Africa.]
3.Collection Date: Sep/28/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [4722]
Test: CD4_PX4722
Result: [0.897]
LNMT Low
[0.5]
High
[2.01]
Unit
10^3/mm3
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829501
Page 11 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
2.Weight: [53.9]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [20.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829502
Page 12 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829503
Page 13 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/29/2020
2.Randomization Number: [101741]
3.Randomization Group: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829504
Page 14 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSD6X]
5.bSample ID [BRSD7J]
5.cSample ID [BM97JL]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829505
Page 15 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM97K0]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829506
Page 16 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 13:54
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829507
Page 17 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829508
Page 18 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829509
Page 19 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829510
Page 20 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829511
Page 21 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829512
Page 22 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829513
Page 23 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM981S]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829514
Page 24 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829515
Page 25 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829516
Page 26 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829517
Page 27 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829518
Page 28 of 229
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
HIV RNA (Ultrasensitive)
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829519
Page 29 of 229
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
CD4_PX4722
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829520
Page 30 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
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 [BRSC5M]
5.bSample ID [BRSC51]
5.cSample ID [BR8171]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829521
Page 31 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829522
Page 32 of 229
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829523
Page 33 of 229
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829524
Page 34 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829525
Page 35 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829526
Page 36 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829527
Page 37 of 229
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829528
Page 38 of 229
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829529
Page 39 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829530
Page 40 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829531
Page 41 of 229
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829532
Page 42 of 229
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829533
Page 43 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829534
Page 44 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829535
Page 45 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829536
Page 46 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829537
Page 47 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829538
Page 48 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829539
Page 49 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829540
Page 50 of 229
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829541
Page 51 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829542
Page 52 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829543
Page 53 of 229
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829544
Page 54 of 229
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829545
Page 55 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829546
Page 56 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829547
Page 57 of 229
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829548
Page 58 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829549
Page 59 of 229
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829550
Page 60 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829551
Page 61 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829552
Page 62 of 229
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829553
Page 63 of 229
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829554
Page 64 of 229
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829555
Page 65 of 229
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829556
Page 66 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829557
Page 67 of 229
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829558
Page 68 of 229
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829559
Page 69 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Exposure during Pregna
ncy Oct/20/2020 10:
25 YES  Repeating
Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829560
Page 70 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Exposure during Pregnancy]
4.Start Date Time: Oct/20/2020 10:25
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:UNKNOWN
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829561
Page 71 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829562
Page 72 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829563
Page 73 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829564
Page 74 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829565
Page 75 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: //
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829566
Page 76 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829567
Page 77 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829568
Page 78 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829569
Page 79 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829570
Page 80 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829571
Page 81 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829572
Page 82 of 229
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829573
Page 83 of 229
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829574
Page 84 of 229
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829575
Page 85 of 229
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829576
Page 86 of 229
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829577
Page 87 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/20/2020
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829578
Page 88 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829579
Page 89 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Leon Fouche  Approved Mar-23-2021 16:28:25 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, LeonFouche, 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.
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829580
Page 90 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-29-2020 10:24:49 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829581
Page 91 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-20-2020 13:56:00 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829582
Page 92 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829583
Page 93 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829584
Page 94 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829585
Page 95 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829586
Page 96 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829587
Page 97 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829588
Page 98 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829589
Page 99 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829590
Page 100 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829591
Page 101 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
10Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829592
Page 102 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
11Oct-20-2020 13:56:00 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829593
Page 103 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829594
Page 104 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Feb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829595
Page 105 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.aFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829596
Page 106 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.bFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829597
Page 107 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.cFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829598
Page 108 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.dFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829599
Page 109 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.eFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829600
Page 110 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.fFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829601
Page 111 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.gFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829602
Page 112 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2.hFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829603
Page 113 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Feb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829604
Page 114 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Feb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829605
Page 115 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829606
Page 116 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829607
Page 117 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cFeb-13-2021 13:33:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829608
Page 118 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829609
Page 119 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829610
Page 120 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829611
Page 121 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829612
Page 122 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829613
Page 123 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829614
Page 124 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829615
Page 125 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:24:47 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829616
Page 126 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829617
Page 127 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829618
Page 128 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829619
Page 129 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829620
Page 130 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829621
Page 131 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829622
Page 132 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829623
Page 133 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-19-2020 18:25:20 (UTC+02:00) Harare,
PretoriaNo update, previously reported.
Not Done
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829624
Page 134 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Nov-16-2020 10:12:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829625
Page 135 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Leon Fouche  Approved Mar-23-2021 16:28:25 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, LeonFouche, 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-13-2021 13:29:04 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Leon Fouche  Approved Jan-12-2021 13:37:01 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, LeonFouche, 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-18-2020 17:25:39 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Leon Fouche  Approved Nov-16-2020 17:08:43 (UTC+02:00) Harare,
PretoriaBOOK Signed
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829626
Page 136 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, LeonFouche, 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 09:11:10 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Leon Fouche  Approved Nov-15-2020 23:11:35 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, LeonFouche, 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.
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829627
Page 137 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-29-2020 10:22:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-29-2020 10:22:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829628
Page 138 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-29-2020 10:22:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/28/2020Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829629
Page 139 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-29-2020 10:22:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12301045Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-29-2020 10:22:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1993Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-29-2020 10:23:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-29-2020 10:23:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-29-2020 10:23:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERICANInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829630
Page 140 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 10:24:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829631
Page 141 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-14-2020 15:48:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-14-2020 07:58:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-14-2020 07:58:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/29/2020Transcription Error
Nov-13-2020 10:24:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Opened DM : Vaccination dose date
is recorded as 29/Sep/2020 .
However, Date of
Completion/Discontinuation
/Death is recorded as
28/Sep/2020. Please review
and update. Else,clarify.
Nov-12-2020 16:22:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Subject was randomized
and received vaccination on
28Sep2020
Nov-12-2020 12:28:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Subject randomized and
received vaccination on
29Sep2020, please confirm
whether this date to be
updated as 29SEP2020 if
appropriate. Else clarify.
Sep-29-2020 10:30:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-29-2020 10:30:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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)
FDA-CBER-2021-5683-0829632
Page 142 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-16-2020
12:04:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Hayley Wyper Query 2:
ClosedResponse satisfies query
Nov-16-2020
09:11:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2:
AnsweredTranscription Error
Nov-16-2020
09:11:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entr
y:
COMPLE
TEDTranscription Error
Nov-14-2020
20:01:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Hayley Wyper Query 2:
OpenedCLINQUERY:
Disposition Screening
has been updated in
error. Please change
back to a status of
COMPLETED here to
indicate screening was
completed and that
subject went on to
receive Vax 1. The
change here will trigger
the EOT tab (Disp Rx
page) to load.
Nov-14-2020
15:50:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Nov-14-2020
07:59:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1:
AnsweredPlease refer to
pregnancy test
performed at V2_Vax2.
Participant had a
negative pregnancy
result on V1_Vax1
Nov-13-2020
10:21:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW5369511;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829633
Page 143 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-12-2020
16:20:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entr
y:
PREGNA
NCYInitial Entry
Nov-12-2020
16:19:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entr
y:Transcription Error
Sep-29-2020
10:30:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entr
y:
COMPLE
TEDInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829634
Page 144 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-29-2020 16:18:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:HIV
Start Date: Sep/UNK/201
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-29-2020 16:18:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 16:18:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
HIVInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-29-2020 16:18:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-29-2020 16:18:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829635
Page 145 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-29-2020 16:19:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term
:C-Section
Start Date: Oct/8/2015
Ongoing: NO
End Date:
Oct/8/201
5Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-29-2020 16:19:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 16:19:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
C-SectionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-29-2020 16:19:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-29-2020 16:19:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/8/2015Initial Entry
1.c
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829636
Page 146 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-22-2020 07:40:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:Preeclampsia
Start Date: Oct/8/2015
Ongoing: NO
End Date:
Oct/8/201
5Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-22-2020 07:40:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 07:40:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
PreeclampsiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-22-2020 07:40:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-22-2020 07:40:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/8/2015Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829637
Page 147 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-02-2020 18:48:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-02-2020 18:10:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered No significant change
in antiretroviral
therapy for at least 6
months.
Oct-01-2020 19:35:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: ongoing
HIV present at
screening. Please
confirm if any
significant change in
antiretroviral therapy
for at least 6 months.
Thanks
Sep-29-2020 16:19:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
The subject is known to be HIV POSI
TIVEInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829638
Page 148 of 229
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Oct-23-2020 15:55:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 18:43:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-22-2020 18:43:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
National Health Laboratory Service,
Thabazimbi Hospital, 10 First Avenu
e, Thabazimbi, Limpopo, South Afri
caTranscription Error
Oct-22-2020 18:22:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened DM: A carriage return
is identified. To avoid
processing errors,
please remove the
identified character
(extra line) by
deleting the entry and
re-entering the data
(without using copy
and paste).
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
National Health Laboratory Service
Thabbazimbi Hospital,
10 First Avenue,
Thabazimbi,
Limpopo,
South Africa,
0380Initial Entry
3. Collection Date:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829639
Page 149 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Jul/14/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Oct-14-2020 12:17:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined
Identifier:2124
Test:: HIV RNA (Ultra
sensitive)
Result:: <20
Lab Normal Ran
ge:Low
20
High
10000000
Unit
/mLTranscription Error
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:2124
Test:: HIV RNA (Ultra
sensitive)
Result:: Undetectable
Lab Normal Ran
ge:Low
20
High
10000000
Unit
/mLInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829640
Page 150 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2124Initial Entry
5.a Test:
Date Location User Value Reason
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
HIV RNA (Ultrasensitive)Initial Entry
5.a Result:
Date Location User Value Reason
Oct-15-2020
13:08:51
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Close
dResponse
satisfies query
Oct-14-2020
12:17:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Oct-14-2020
12:17:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
<20Transcription
Error
Oct-14-2020
11:51:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Open
edLab Result is not
valid and should
be a numeric
value. Please
review and
update as
necessary based
on the Reference
Range provided
in the Lab
Records (please
ensure no
commas or
ranges).
Sep-29-2020
16:37:15
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UndetectableInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829641
Page 151 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a LNMT
Date Location User Value Reason
Sep-29-2020 16:37:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Low
20
High
10000000
Unit
/mLInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829642
Page 152 of 229
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-29-2020 16:29:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Oct-23-2020 15:55:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 18:40:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-22-2020 18:40:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Lacet Thabazimbi, Carpediem Medi
cal Centre, 13th Avenue, Thabazimb
i, Limpop, South Africa.Transcription Error
Oct-22-2020 18:22:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened DM: A carriage return
is identified. To avoid
processing errors,
please remove the
identified character
(extra line) by
deleting the entry and
re-entering the data
(without using copy
and paste).
Sep-29-2020 16:41:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Lancet Thabazimbi,
Carpediem Medical Centre,
13th Avenue,
Thabazimbi,
Limpopo,
South AfricaInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-29-2020 16:31:45
(UTC+02:00) Harare,ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829643
Page 153 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Pretoria
Sep-29-2020 16:29:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection date is
updated, but result is
missing. Please
correct or confirm.
Sep-29-2020 16:29:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Sep-29-2020 16:29:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Nov-13-2020 08:06:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:4722
Test:: CD4_PX47
22
Result:: 0.897
Lab Normal Range: Low
0.5
High
2.01
Unit
10^3/mm
3Transcription Error
Nov-13-2020 08:05:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:4722
Test:: CD4_PX47
22
Result:: 0.897Transcription Error
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829644
Page 154 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Normal Range: Low
500
High
2010
Unit
10^3/mm
3
Sep-29-2020 16:39:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:4722
Test:: CD4_PX47
22
Result:: 897
Lab Normal Range: Low
500
High
2010
Unit
10^3/mm
3Transcription Error
Sep-29-2020 16:31:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ident
ifier:4722
Test:: CD4_PX47
22
Result:: 897
Lab Normal Range: Low
500
High
2010Initial Entry
Sep-29-2020 16:31:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:
Test:: CD4_PX47
22
Result::
Lab Normal Range: Low
500
High
2010Transcription Error
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829645
Page 155 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020 16:21:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:
Test:: CD4_PX47
22
Result::
Lab Normal Range: Low
-Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Sep-29-2020 16:31:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4722Initial Entry
5.a Test:
Date Location User Value Reason
Sep-29-2020 16:21:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CD4_PX4722Initial Entry
5.a Result:
Date Location User Value Reason
Nov-13-2020 08:46:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Salim
BouguermouhQuery 2: Closed Response satisfies
query
Nov-13-2020 08:05:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Nov-13-2020 08:05:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
0.897Transcription Error
Nov-13-2020 04:47:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Salim
BouguermouhQuery 2: Opened Clin: Please enter the
CD4 absolute values
only, LNMT Low and
LNMT High, after
dividing the number
by 1000 to allow
using the Unit
provided “10^3/mm3”
equivalent to
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829646
Page 156 of 229
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
“1000/mm3”
Sep-29-2020 16:39:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-29-2020 16:31:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present, but
lab normal range
(Low, high or Unit) is
missing. Please
correct or confirm.
Sep-29-2020 16:31:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
897Initial Entry
5.a LNMT
Date Location User Value Reason
Nov-13-2020 08:06:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Low
0.5
High
2.01
Unit
10^3/mm3Transcription Error
Sep-29-2020 16:39:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Low
500
High
2010
Unit
10^3/mm3Transcription Error
Sep-29-2020 16:31:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Low
500
High
2010Transcription Error
Sep-29-2020 16:21:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Low
-Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829647
Page 157 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 08:26:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-13-2020 09:29:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Participant was
screened over two
consecutive days.
Oct-12-2020 15:26:19
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened Vital Signs Date is
not the same as
Vaccination Date in
the same visit. Please
review and update as
appropriate or clarify.
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
53.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
162.0Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829648
Page 158 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5. Unit:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.5Initial Entry
7.a
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829649
Page 159 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-29-2020 16:43:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829650
Page 160 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 09:35:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Closed per SITE
response, added to PD
tracker
Sep-30-2020 18:07:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-30-2020 12:46:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened PDQ: Date of the
pregnancy test does is
not the same day as
the vaccination.
Please review and
correct or confirm.
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829651
Page 161 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-29-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829652
Page 162 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-29-2020 16:44:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-29-2020 16:44:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
101741Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829653
Page 163 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 16:19:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 16:19:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 16:19:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 16:19:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-29-2020 16:19:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 16:19:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSD6XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:19:46 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0829654
Page 164 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaBRSD6X
5.b
Date Location User Value Reason
Sep-29-2020 16:20:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSD7JInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 16:20:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSD7JInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 16:20:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM97JLInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 16:20:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM97JLInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829655
Page 165 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 16:20:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 16:20:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 16:20:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 16:20:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-29-2020 16:20:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 16:20:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM97K0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:20:55 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0829656
Page 166 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaBM97K0
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829657
Page 167 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020 21:04:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-20-2020 09:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Per protocol,
participant was
screened over two
consecutive days
while site awaited lab
results.
Oct-19-2020 21:58:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened CLINQUERY: Temp
delay = no, however,
vaccine date =
29/SPET/20 and
DOV = 28/SEPT/20.
Oct-19-2020 16:32:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Candidate CLINQUERY: Temp
delay = no, however,
vaccine date =
29/SPET/20 and
DOV = 28/SEPT/20.
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829658
Page 168 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sep/29/2020 13:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-29-2020 16:45:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829659
Page 169 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-29-2020 16:45:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829660
Page 170 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 13:09:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829661
Page 171 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829662
Page 172 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829663
Page 173 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829664
Page 174 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: NEW ORInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829665
Page 175 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Pretoria WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829666
Page 176 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Symptom:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829667
Page 177 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829668
Page 178 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:11:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829669
Page 179 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2.a
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829670
Page 180 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-20-2020 17:41:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829671
Page 181 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: POSITIVEInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829672
Page 182 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020 12:20:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-21-2020 10:21:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Second vaccination
has been withheld.
Reported SAE and
EDP to sponsora and
loaded SAE on EDC.
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Lab result is
“Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
Oct-20-2020 13:10:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829673
Page 183 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:10:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:10:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:11:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:10:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-20-2020 13:10:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:11:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM981SInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:11:17 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0829674
Page 184 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaBM981S
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829675
Page 185 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-20-2020 13:56:00 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829676
Page 186 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaNot Done
7. Route:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-20-2020 13:56:00
(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-20-2020 13:56:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829677
Page 187 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 17:25:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829678
Page 188 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
Feb-15-2021 09:48:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Data updated by site.
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:29:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-13-2021 13:29:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Feb-09-2021 14:46:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened eDiary: Vaccination 2
is ‘Not Done’ and
eDiary data not
available however
corresponding
‘Symptom Resolved
CRF’ in visit 3 is
entered with data.
Kindly verify and
consider updating
form level comment
as Not Applicable.
Thanks!
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FEV
ERInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829679
Page 189 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Not
Appli
cable
Feb-13-2021 13:29:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:29:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829680
Page 190 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FATI
GUE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Not
Appli
cableInitial Entry
Feb-13-2021 13:29:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829681
Page 191 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:29:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Not
Appli
cableInitial Entry
Feb-13-2021 13:30:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DACInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829682
Page 192 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.c Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:30:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CHI
LLS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Not
Appli
cableInitial Entry
Feb-13-2021 13:30:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
STranscription Error
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829683
Page 193 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:30:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VOM
ITIN
GInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829684
Page 194 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cable
Feb-13-2021 13:31:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:31:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829685
Page 195 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Not
Appli
cableInitial Entry
Feb-13-2021 13:32:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829686
Page 196 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:32:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Not Applic
ableInitial Entry
Feb-13-2021 13:32:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Transcription Error
Nov-18-2020 17:26:08 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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) (4), (b) 
(6)
FDA-CBER-2021-5683-0829687
Page 197 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaSymptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:32:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:Not Applic
ableInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829688
Page 198 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.h
Date Location User Value Reason
Feb-13-2021 13:32:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:32:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829689
Page 199 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
3. Injection Site Location:
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:29:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:31:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not
Appli
cableInitial Entry
Feb-13-2021 13:32:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESSTranscription Error
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829690
Page 200 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:32:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
GInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829691
Page 201 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not A
pplica
ble
Feb-13-2021 13:32:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:32:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829692
Page 202 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c
Date Location User Value Reason
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Not App
licableInitial Entry
Feb-13-2021 13:31:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829693
Page 203 of 229
***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: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020 17:26:08
(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
Feb-13-2021 13:33:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-13-2021 13:31:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-18-2020 17:26:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829694
Page 204 of 229
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Specimen Type:
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identifie
r:Not Don
e
Test:: Not Don
e
Result:: Not Don
e
Lab Normal Range: Not Don
eInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829695
Page 205 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a Test:
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a Result:
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a LNMT
Date Location User Value Reason
Nov-19-2020 18:24:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829696
Page 206 of 229
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Specimen Type:
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identifie
r:Not Don
e
Test:: Not Don
e
Result:: Not Don
e
Lab Normal Range: Not Don
eInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829697
Page 207 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a Test:
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a Result:
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5.a LNMT
Date Location User Value Reason
Nov-19-2020 18:25:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829698
Page 208 of 229
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 17:26:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 17:26:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020 17:26:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020 17:26:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSC5MInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-18-2020 17:26:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSC5MInitial Entry
5.b
Date Location User Value Reason
Nov-18-2020 17:26:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSC51Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829699
Page 209 of 229
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b Sample ID
Date Location User Value Reason
Nov-18-2020 17:26:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSC51Initial Entry
5.c
Date Location User Value Reason
Nov-18-2020 17:26:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BR8171Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020 17:26:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BR8171Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829700
Page 210 of 229
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-16-2020 13:12:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020 13:12:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-16-2020 23:58:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Current status of
Pregnancy is okay per
completion guidelines.
Nov-16-2020 20:40:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened DM: The AE
"Exposure during
Pregnancy" has the
Action Taken as
DRUG
WITHDRAWN;
however, the reason
for treatment
discontinuation is not
reported as ADVERSE
EVENT. If AE is
reason for treatment
discontinued, the EOT
should match. Please
review and confirm.
Nov-16-2020 13:12:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
PREGNANCYInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829701
Page 211 of 229
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829702
Page 212 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 08:42:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-03-2021 09:01:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Updated SAE form
will be sent
Jan-27-2021 00:12:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened Clinical Event term is
Exposure during
pregnancy; however,
SAE event term is
EDP. Please submit a
SAE safety FAX to
update term from the
abbreviation.
Jan-26-2021 00:53:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Candidate Clinical Event term is
Exposure during
pregnancy; however,
SAE event term is
EDP. Please submit a
SAE safety FAX to
update term from the
abbreviation.
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Exposure during PregnancyInitial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829703
Page 213 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 17:49:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-16-2020 17:35:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Per Clinical
confirmation onset
date of 20Oct2020
Acceptable
Nov-16-2020 14:57:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Candidate For Clinical
confirmation
Nov-16-2020 14:07:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Answered Changed data per
query
Nov-16-2020 14:07:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Follow-up report sent,
clarified with clinician
that onset date will
remain as 20-Oct-2020
as LMP cannot be
established.
Nov-16-2020 13:23:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Opened Please respond to
clinician query stating
that follow-up report
sent, clarified with
clinician that onset
date will remain as
20-Oct-2020 as no
LMP can be
established.
Nov-04-2020 13:37:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 2: Per
Clinical review 'the
correct onset date is
28Sep2020.Please
update the onset date
in the AE log and
submit a form to
update SDB
Nov-04-2020 09:05:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Pregnancy test was
conducted on visit1
and confirmed
negative. No
ultrasound was
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829704
Page 214 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
performed on 20 OCT
2020 when the
participant first tested
positive, thus unable to
establish wether date
of conception was
prior to Visit 1. Please
advise on further
action.
Nov-03-2020 13:41:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1:PER
EDP guidelines, If
conception occurred
prior to vaccination 1,
Date of AE Onset =
Date of vaccination.Per
Clinical review 'the
correct onset date is
28Sep2020.Please
update the onset date
in the AE log and
submit a form to
update SDB
Oct-31-2020 15:44:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Candidate SAE RECON: For
Clinical review
Oct-30-2020 18:20:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Participant had a
negative pregnancy
test on DOV1.
Investigator (and
participant) only
became aware of
pregnancy after
positive pregnancy test
on DOV2.
Oct-30-2020 14:30:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened SAE RECON:
AE#2020408343, Per
Clinical review 'the
correct onset date for
the EDP is DOV 1 =>
28Sep2020. Please
update the onset date
in the AE log and
submit a fu SAE form
with the correction'
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/20/2020 10:25Initial Entry
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0829705
Page 215 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 17:12:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-16-2020 10:12:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 10:12:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-16-2020 10:12:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry: Transcription Error
Nov-15-2020 08:40:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Toxicity grade is not
expected for
pregnancy related
adverse events, hence
please remove the
toxicity and add item
level comment as
NOT APPLICABLE.
Oct-21-2020 10:18:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
090177e196ae303d\Final\Final On: 01-Apr-2021 04:05 (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) (4)
FDA-CBER-2021-5683-0829706
Page 216 of 229
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-16-2020 13:17:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 4: Closed non serious in both database
Nov-16-2020 11:58:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 4: Answered SAE was initially reported but
de-escalated to NON-serious
even
…[truncated]