Document text
Page 1 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829302
Page 2 of 190
***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: 12301025 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/25/2020
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829303
Page 3 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12301025]
2.Birth Date: UNK/UNK/1946
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829304
Page 4 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829305
Page 5 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829306
Page 6 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829307
Page 7 of 190
***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: 12301025 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:[Bilateral lens replacement]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2007
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal Hernia Repair]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829308
Page 8 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal Hernia Repair]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparotomy for tumour excision]
Start Date: Oct/27/2014
Ongoing: NO
End Date:
Oct/27/2014
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastric Carcinoma]
Start Date: Oct/UNK/2014
Ongoing: NO
End Date:
Oct/27/2014
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chemotherapy]
Start Date: Feb/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829309
Page 9 of 190
***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: 12301025 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 NOT known to be HIV POSITIVE
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829310
Page 10 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [76.4]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829311
Page 11 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [265253]
3.Randomization Group: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829312
Page 12 of 190
***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: 12301025 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/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSD3V]
5.bSample ID [BRSD48]
5.cSample ID [BM97FF]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829313
Page 13 of 190
***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: 12301025 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/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM97F0]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829314
Page 14 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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/25/2020 10:47
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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829315
Page 15 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829316
Page 16 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829317
Page 17 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829318
Page 18 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829319
Page 19 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829320
Page 20 of 190
***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: 12301025 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/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR810J]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829321
Page 21 of 190
***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: 12301025 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: Oct/16/2020 12:02
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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829322
Page 22 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829323
Page 23 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829324
Page 24 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829325
Page 25 of 190
***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: 12301025 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/13/2020
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 [BRSC21]
5.bSample ID [BRSC1S]
5.cSample ID [BR8153]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829326
Page 26 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829327
Page 27 of 190
***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: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829328
Page 28 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829329
Page 29 of 190
***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: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829330
Page 30 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829331
Page 31 of 190
***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: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829332
Page 32 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829333
Page 33 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12301025 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: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829334
Page 34 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829335
Page 35 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829336
Page 36 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12301025 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?
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829337
Page 37 of 190
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829338
Page 38 of 190
***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: 12301025 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:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829339
Page 39 of 190
***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: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829340
Page 40 of 190
***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: 12301025 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:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829341
Page 41 of 190
***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: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829342
Page 42 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829343
Page 43 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829344
Page 44 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/3/2021
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829345
Page 45 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Mar/3/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829346
Page 46 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829347
Page 47 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829348
Page 48 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829349
Page 49 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829350
Page 50 of 190
***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: 12301025 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:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829351
Page 51 of 190
***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: 12301025 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?
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829352
Page 52 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829353
Page 53 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829354
Page 54 of 190
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829355
Page 55 of 190
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829356
Page 56 of 190
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829357
Page 57 of 190
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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 [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829358
Page 58 of 190
***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: 12301025 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: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829359
Page 59 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829360
Page 60 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829361
Page 61 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Id
entifie
rAdverse EventStart Da
teIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
1.ADVERS
E EVENT
1 Penile Intra Epithelial Neoplasia Nov/6/20
20 16:24 YES Repeating
Pages
2.ADVERS
E EVENT
2 PENILE INVASIVE MODERATELY DIFFEREN
TIAL KERATINIZING SQUAMOUS CELL CAR
CINOMA Nov/6/20
20 16:24 YES Repeating
Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829362
Page 62 of 190
***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: 12301025 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)[Penile Intra Epithelial Neoplasia]
4.Start Date Time: Nov/6/2020 16:24
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829363
Page 63 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
[Neoplasia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020451162]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829364
Page 64 of 190
***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: 12301025 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[PENILE INVASIVE MODERATELY DIFFERENTIAL KERATINIZING
SQUAMOUS CELL CARCINOMA]
4.Start Date Time: Nov/6/2020 16:24
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CANCER]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829365
Page 65 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829366
Page 66 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829367
Page 67 of 190
***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: 12301025 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[ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829368
Page 68 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829369
Page 69 of 190
***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: 12301025 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: //
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829370
Page 70 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829371
Page 71 of 190
***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: 12301025 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?
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829372
Page 72 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829373
Page 73 of 190
***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: 12301025 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?
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829374
Page 74 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829375
Page 75 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829376
Page 76 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829377
Page 77 of 190
***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: 12301025 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?
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829378
Page 78 of 190
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829379
Page 79 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829380
Page 80 of 190
***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: 12301025 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: [ ]
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829381
Page 81 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/13/2020
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829382
Page 82 of 190
***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: 12301025 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
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829383
Page 83 of 190
***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: 12301025 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-24-2021 18:25:12 (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.
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829384
Page 84 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-25-2020 11:39:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829385
Page 85 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829386
Page 86 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Mar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829387
Page 87 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Mar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829388
Page 88 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Mar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829389
Page 89 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4.aMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829390
Page 90 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4.bMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829391
Page 91 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829392
Page 92 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829393
Page 93 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829394
Page 94 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829395
Page 95 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829396
Page 96 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829397
Page 97 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829398
Page 98 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 hMar-04-2021 13:30:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829399
Page 99 of 190
***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: 12301025 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-24-2021 18:25:12 (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 Mar-24-2021 18:18:50 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Leon Fouche Approved Mar-23-2021 12:56:48 (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 Jan-27-2021 16:26:59 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829400
Page 100 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Leon Fouche Approved Jan-22-2021 16:03:34 (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 Jan-15-2021 10:25:24 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Leon Fouche Approved Nov-15-2020 23:03:38 (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.
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829401
Page 101 of 190
***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: 12301025 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-25-2020 11:37:57
(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-25-2020 11:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829402
Page 102 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020 11:38:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829403
Page 103 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 11:37:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12301025Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-30-2020
21:36:04
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_DM001_03
Sep-30-2020
14:49:43
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-30-2020
14:49:43
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data E
ntry:
UNK/U
NK/19
46Transcription Error
Sep-30-2020
12:45:52
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
1: Open
edDMW4821239;Site
is in Germany or
South Africa,
however Date of
Birth is complete.
Sep-28-2020
16:02:28
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Cand
idateDMW4818977;Site
is in Germany or
South Africa,
however Date of
Birth is complete.
Sep-25-2020
11:37:45
(UTC+02:00)
Harare,ACV0PFEINFP6000 auto calc (autocalc) Data E
ntry:
1946Enrollment Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829404
Page 104 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Pretoria
3. Sex:
Date Location User Value Reason
Sep-25-2020 11:38:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 11:38:32
(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-25-2020 11:38:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae303e\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-2021-5683-0829405
Page 105 of 190
***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: 12301025 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-25-2020 11:38:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829406
Page 106 of 190
***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: 12301025 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
Sep-25-2020 11:39:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 11:39:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 11:39:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829407
Page 107 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-25-2020 11:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Bilateral lens repl
acement
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/20
10Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:40:49
(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-25-2020 11:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Bilateral lens replacementInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-25-2020 11:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829408
Page 108 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-25-2020 11:40:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.b
Date Location User Value Reason
Sep-25-2020 11:41:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Tonsillectomy
Start Date: UNK/UNK/196
0
Ongoing: NO
End Date:
UNK/UNK/
1960Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829409
Page 109 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:41:46
(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-25-2020 11:41:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
TonsillectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-25-2020 11:41:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/1960Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-25-2020 11:41:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1960Initial Entry
1.c
Date Location User Value Reason
Sep-25-2020 11:42:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
007Initial Entry
090177e196ae303e\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-2021-5683-0829410
Page 110 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:42:33
(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
Sep-25-2020 11:42:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-25-2020 11:42:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-25-2020 11:42:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-25-2020 11:44:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical Histor
y Term:Inguinal Hernia
RepairInitial Entry
090177e196ae303e\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-2021-5683-0829411
Page 111 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Start Date: UNK/UNK/199
5
Ongoing: NO
End Date:
UNK/UNK/1
995
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:44:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 11:44:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Inguinal Hernia RepairInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-25-2020 11:44:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020 11:44:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1995Initial Entry
1.e
Date Location User Value Reason
090177e196ae303e\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-2021-5683-0829412
Page 112 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-25-2020 11:44:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:Inguinal Hernia
Repair
Start Date: UNK/UNK/200
5
Ongoing: NO
End Date:
UNK/UNK/2
005Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829413
Page 113 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:44:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 11:44:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Inguinal Hernia RepairInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020 11:44:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020 11:44:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.f
Date Location User Value Reason
Sep-25-2020 12:04:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Laparotomy for tu
mour excision
Start Date: Oct/27/2014Transcription Error
090177e196ae303e\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-2021-5683-0829414
Page 114 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Ongoing: NO
End Date:
Oct/27/2014
Sep-25-2020 11:49:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Laparotomy tum
our excision
Start Date: Oct/27/2014
Ongoing: NO
End Date:
Oct/27/2014Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829415
Page 115 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.f Line/MH Number:
Date Location User Value Reason
Sep-25-2020 11:49:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 12:04:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Laparotomy for tumour excisionTranscription Error
Sep-25-2020 11:49:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Laparotomy tumour excisionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-25-2020 11:49:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/27/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-25-2020 11:49:35
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/27/2014Initial Entry
1.g
Date Location User Value Reason
Sep-25-2020 12:00:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7Initial Entry
090177e196ae303e\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-2021-5683-0829416
Page 116 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Medical History
Term:Gastric Carcin
oma
Start Date: Oct/UNK/201
4
Ongoing: NO
End Date:
Oct/27/201
4
1.g Line/MH Number:
Date Location User Value Reason
Sep-25-2020 12:00:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 12:00:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Gastric CarcinomaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-25-2020 12:00:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-25-2020 12:00:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/27/2014Initial Entry
1.h
090177e196ae303e\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-2021-5683-0829417
Page 117 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-25-2020 12:01:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Chemotherapy
Start Date: Feb/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829418
Page 118 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.h Line/MH Number:
Date Location User Value Reason
Sep-25-2020 12:01:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 12:01:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ChemotherapyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-25-2020 12:01:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Feb/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-25-2020 12:01:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae303e\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-2021-5683-0829419
Page 119 of 190
***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: 12301025 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
Sep-25-2020 12:02:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829420
Page 120 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
76.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
175.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae303e\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-2021-5683-0829421
Page 121 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.9Initial Entry
7.a
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae303e\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-2021-5683-0829422
Page 122 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-25-2020 12:03:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829423
Page 123 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 12:04:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020 12:04:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
265253Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829424
Page 124 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 12:07:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 12:07:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 12:07:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 12:05:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSD3VInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 12:05:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSD3VInitial Entry
090177e196ae303e\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-2021-5683-0829425
Page 125 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b
Date Location User Value Reason
Sep-25-2020 12:05:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSD48Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-25-2020 12:05:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSD48Initial Entry
5.c
Date Location User Value Reason
Sep-28-2020 16:40:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM97FFInitial Entry
Sep-28-2020 16:39:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Sep-25-2020 12:05:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM97FFInitial Entry
090177e196ae303e\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-2021-5683-0829426
Page 126 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Sample ID
Date Location User ValueReason
Sep-28-2020
21:34:41
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-28-2020
16:40:41
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
BM97
FFInitial Entry
Sep-28-2020
16:39:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Sep-28-2020
16:39:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:Transcription Error
Sep-28-2020
12:43:26
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4819006;The
Barcode BM97FF is
recorded for two
subjects 12301024
and 12301025. Two
different subjects can
not have same
barcodes. Please
review and update as
appropriate.
Sep-25-2020
12:05:52
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
BM97
FFInitial Entry
090177e196ae303e\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-2021-5683-0829427
Page 127 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 12:12:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 12:12:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 12:12:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 12:12:31
(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-25-2020 12:12:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 12:12:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM97F0Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829428
Page 128 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 12:12:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM97F0Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829429
Page 129 of 190
***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, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 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
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-24-2021 18:18:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020 10:47Transcription Error
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/25/2020 11:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae303e\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-2021-5683-0829430
Page 130 of 190
***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, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Side:
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-25-2020 12:13:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829431
Page 131 of 190
***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: 12301025 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-25-2020 12:13:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829432
Page 132 of 190
***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: 12301025 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-16-2020 12:36:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829433
Page 133 of 190
***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: 12301025 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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae303e\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-2021-5683-0829434
Page 134 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829435
Page 135 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829436
Page 136 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829437
Page 137 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829438
Page 138 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829439
Page 139 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829440
Page 140 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Symptom:
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829441
Page 141 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829442
Page 142 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829443
Page 143 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-16-2020 12:37:07
(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-16-2020 12:37:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829444
Page 144 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae303e\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-2021-5683-0829445
Page 145 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 12:37:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829446
Page 146 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 15:04:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 15:04:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 15:05:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 15:04:56
(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-16-2020 15:04:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 15:05:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BR810JInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829447
Page 147 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 15:05:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BR810JInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829448
Page 148 of 190
***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: 12301025 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-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/16/2020 12:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829449
Page 149 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 12:37:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829450
Page 150 of 190
***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: 12301025 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-14-2020 16:16:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829451
Page 151 of 190
***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: 12301025 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
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae303e\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-2021-5683-0829452
Page 152 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829453
Page 153 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae303e\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-2021-5683-0829454
Page 154 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829455
Page 155 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae303e\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-2021-5683-0829456
Page 156 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae303e\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-2021-5683-0829457
Page 157 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-14-2020 16:17:04
(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
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae303e\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-2021-5683-0829458
Page 158 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-14-2020 16:17:04
(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
Nov-14-2020 16:17:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae303e\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-2021-5683-0829459
Page 159 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-14-2020 16:18:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-14-2020 16:18:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-14-2020 16:18:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-14-2020 16:17:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSC21Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-14-2020 16:17:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSC21Initial Entry
5.b
Date Location User Value Reason
090177e196ae303e\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-2021-5683-0829460
Page 160 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-14-2020 16:17:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSC1SInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-14-2020 16:17:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSC1SInitial Entry
5.c
Date Location User Value Reason
Nov-14-2020 16:18:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BR8153Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-14-2020 16:18:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BR8153Initial Entry
090177e196ae303e\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-2021-5683-0829461
Page 161 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 13:27:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829462
Page 162 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Assessments
Date Location User Value Reason
Mar-04-2021 13:28:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-04-2021 13:27:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update
as appropriate.
Mar-04-2021 13:27:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829463
Page 163 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-04-2021 13:28:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-08-2021 12:46:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Deleted Data updated
Mar-04-2021 13:28:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but no
'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL
REACTION' form(s)
is/are entered. Please
review and update as
appropriate.
Mar-04-2021 13:28:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Mar/3/2021
Contact Outcome:
VISIT ARRANGEDInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829464
Page 164 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
2.a
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae303e\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-2021-5683-0829465
Page 165 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-04-2021 13:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829466
Page 166 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-05-2021
23:10:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
1: Clos
edResponse satisfies
query
Mar-05-2021
17:09:28
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
1: Ans
weredPARTICIPANT
CAME FOR
FOLLOW UP ON
SAE. NO
SYMPTOMS
REPORTED
Mar-05-2021
12:51:06
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7598049;Date
of Assessment is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Mar-04-2021
13:30:51
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data E
ntry:
Not Ap
plicabl
eInitial Entry
2. Injection Site Location
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
090177e196ae303e\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)
FDA-CBER-2021-5683-0829467
Page 167 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.a
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Reaction:: Not Applicabl
e
Reaction Present
::Not Applicabl
eInitial Entry
4.a Reaction:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Reaction:: Not Applicabl
e
Reaction Present
::Not Applicabl
eInitial Entry
090177e196ae303e\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-2021-5683-0829468
Page 168 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.b Reaction:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
5.a Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
Mar-04-2021 13:30:51 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae303e\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-2021-5683-0829469
Page 169 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaSymptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
le
5.b Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
5.c Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae303e\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-2021-5683-0829470
Page 170 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.d
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
5.d Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.e
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
090177e196ae303e\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-2021-5683-0829471
Page 171 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.e Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.f
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
5.f Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.g
Date Location User Value Reason
Mar-04-2021 13:30:51 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae303e\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-2021-5683-0829472
Page 172 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Mar/03/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC+02:00) Harare,
PretoriaSymptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
le
5.g Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.h
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicab
le
Symptom Presen
t::Not Applicab
leInitial Entry
5.h Symptom:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Mar-04-2021 13:30:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae303e\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-2021-5683-0829473
Page 173 of 190
***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: 12301025 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 16:18:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-14-2020 16:18:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-14-2020 16:18:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829474
Page 174 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 16:26:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829475
Page 175 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-27-2021 16:27:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 16:27:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-27-2021 16:27:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829476
Page 176 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829477
Page 177 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829478
Page 178 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-14-2020 16:43:37
(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
Jan-22-2021 13:36:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-22-2021 09:18:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Answered Yes new diagnosis
added. No prior
diagnosis of other
Penile Dysplasia
Jan-20-2021 18:15:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Opened clinical: pls confirm
this is a new
diagnosis for subject
and has no prior hx
of dysplasia. Thanks
Dec-03-2020 19:56:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Further
clarifications are
being addressed
through CRA.
Nov-25-2020 13:54:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered As per Treating
Physician penile
intraepithelial
neoplasia was noted
as high grade.
090177e196ae303e\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)
FDA-CBER-2021-5683-0829479
Page 179 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-24-2020 22:17:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Reissued:Opened GPD Clin: Cancers
that haven't invaded
beyond epithelium
of penis are known
as carcinoma in situ
(CIS) or penile
intraepithelial
neoplasia. Please
consult with PI
update term and
submit SAE FU
report, as
applicable, else
clarify in query
response. Thanks
Nov-24-2020 08:30:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered Not benign and not
described as in-situ.
Nov-21-2020 00:26:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: per data
in safety database
participant was
diagnosed with
“High grade
neoplasia", while
eCRF verbatim is
“Intra Epithelial
Neoplasia”. Please
confirm if
participant has
benign or in-situ
penile neoplasm?
Thanks
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Penile Intra Epithelial NeoplasiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/6/2020 16:24Initial Entry
090177e196ae303e\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-2021-5683-0829480
Page 180 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-15-2020 13:01:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Penile Intra
Epithelial
Neoplasia :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birtInitial Entry
090177e196ae303e\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-2021-5683-0829481
Page 181 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-24-2020 17:42:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed closed based on
site's response
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829482
Page 182 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-24-2020 07:35:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered None noted in
source.
Nov-21-2020 00:28:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Please
confirm if
participant had any
abnormalities that
could have been
suggestive for Intra
Epithelial Neoplasia
at baseline and
update MH eCRF
page, as applicable.
Thanks
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
NeoplasiaInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae303e\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)
FDA-CBER-2021-5683-0829483
Page 183 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-14-2020 16:43:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-15-2020 13:01:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2020451162Initial Entry
090177e196ae303e\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-2021-5683-0829484
Page 184 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021 19:18:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Jan-22-2021 09:25:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Updated to PENILE
INVASIVE
MODERATELY
DIFFERENTIAL
KERATINIZING
SQUAMOUS CELL
CARCINOMA
Jan-22-2021 09:25:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
PENILE INVASIVE MODERA
TELY DIFFERENTIAL KERA
TINIZING SQUAMOUS CELL
CARCINOMAUpdated to PENILE
INVASIVE
MODERATELY
DIFFERENTIAL
KERATINIZING
SQUAMOUS CELL
CARCINOMA
Jan-19-2021 16:47:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Can you
please adjust the
term "INVASIVE
MODERATELY
DIFFERENTIAL
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829485
Page 185 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
KERATINIZING
SQUAMOUS CELL
CARCINOMA" to
add anatomical
location/organ?
Thank you
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
INVASIVE MODERATELY DI
FFERENTIAL KERATINIZIN
G SQUAMOUS CELL CARCI
NOMAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/6/2020 16:24Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-15-2021 10:35:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
3Transcription Error
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae303e\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-2021-5683-0829486
Page 186 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
CANCERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae303e\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-2021-5683-0829487
Page 187 of 190
***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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-15-2021 10:25:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae303e\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-2021-5683-0829488
Page 188 of 190
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021 16:27:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021 16:27:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829489
Page 189 of 190
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1230 Site Name: (1230) Tamboti Medical Centre
Subject No: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-14-2020 16:18:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-25-2020 12:04:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-25-2020 11:39:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-14-2020 16:18:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/13/2020Initial Entry
Sep-25-2020 12:04:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-25-2020 11:39:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829490
Page 190 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail 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: 12301025 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 14:29:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae303e\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829491