125742 S1 M5 CRF c4591001 1247 12471226

Document text

Page 1 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894436
Page 2 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/8/2020
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894437
Page 3 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471226]
2.Birth Date: UNK/UNK/1980
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
WHITE
6.Racial Designation:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894438
Page 4 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894439
Page 5 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894440
Page 6 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894441
Page 7 of 223
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Achalasia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major depressive disorder]
Start Date: Apr/UNK/2020
Ongoing: YES
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894442
Page 8 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894443
Page 9 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
2.Weight: [45.1]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [15.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [35.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894444
Page 10 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/8/2020
2.Randomization Number: [105052]
3.Randomization Group: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894445
Page 11 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BRSTGB]
5.bSample ID [BM9CVF]
5.cSample ID [BRSTGG]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894446
Page 12 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BM9CVR]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894447
Page 13 of 223
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/8/2020 10:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894448
Page 14 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894449
Page 15 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894450
Page 16 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894451
Page 17 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location:
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894452
Page 18 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894453
Page 19 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9FMC]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894454
Page 20 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/30/2020 17:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894455
Page 21 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894456
Page 22 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894457
Page 23 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894458
Page 24 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
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 [BR7MSP]
5.bSample ID [BRY9TG]
5.cSample ID [BRY9TH]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894459
Page 25 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894460
Page 26 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894461
Page 27 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894462
Page 28 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894463
Page 29 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894464
Page 30 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894465
Page 31 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894466
Page 32 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894467
Page 33 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894468
Page 34 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894469
Page 35 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894470
Page 36 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894471
Page 37 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894472
Page 38 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894473
Page 39 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894474
Page 40 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894475
Page 41 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894476
Page 42 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894477
Page 43 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Severe depressive epi
sode Feb/4/2021 UNK:
UNK NO
End Date Time:
Feb/8/2021 UNK:UNK
 Repeating
Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894478
Page 44 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Severe depressive episode]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/8/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Etiology to be confirmed]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894479
Page 45 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021122861]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894480
Page 46 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.Not Applica
ble Not Applicable
 Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894481
Page 47 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894482
Page 48 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applic
able Repeating
Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894483
Page 49 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894484
Page 50 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894485
Page 51 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894486
Page 52 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894487
Page 53 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894488
Page 54 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894489
Page 55 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894490
Page 56 of 223
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894491
Page 57 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894492
Page 58 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894493
Page 59 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894494
Page 60 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894495
Page 61 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894496
Page 62 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894497
Page 63 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894498
Page 64 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894499
Page 65 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894500
Page 66 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894501
Page 67 of 223
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894502
Page 68 of 223
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894503
Page 69 of 223
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894504
Page 70 of 223
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894505
Page 71 of 223
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894506
Page 72 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/4/2020
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894507
Page 73 of 223
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894508
Page 74 of 223
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894509
Page 75 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-08-2020 14:18:22 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894510
Page 76 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-02-2020 12:35:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894511
Page 77 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-02-2020 12:35:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894512
Page 78 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.bNov-02-2020 12:36:12 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894513
Page 79 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.cNov-02-2020 12:36:22 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894514
Page 80 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.dNov-02-2020 12:36:32 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894515
Page 81 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.eNov-02-2020 12:36:42 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894516
Page 82 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.fNov-02-2020 12:36:53 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894517
Page 83 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.gNov-02-2020 12:37:04 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894518
Page 84 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.hNov-02-2020 12:37:14 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894519
Page 85 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-02-2020 12:37:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894520
Page 86 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-02-2020 12:37:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894521
Page 87 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-02-2020 12:37:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894522
Page 88 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894523
Page 89 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894524
Page 90 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894525
Page 91 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.bDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894526
Page 92 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.cDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894527
Page 93 of 223
***Confidential***
Header Text: c4591001
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
2.dDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.eDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.fDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.gDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.hDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
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Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-04-2020 13:30:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894540
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894542
Page 108 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894543
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Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894547
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Feb-06-2021 14:00:02 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894552
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Feb-06-2021 14:00:20 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894560
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894561
Page 127 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894562
Page 128 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894563
Page 129 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894564
Page 130 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Feb-06-2021 14:00:46 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894565
Page 131 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894566
Page 132 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894567
Page 133 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894568
Page 134 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894569
Page 135 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894570
Page 136 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894571
Page 137 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Feb-06-2021 14:01:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894572
Page 138 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-06-2021 14:01:38 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894573
Page 139 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-06-2021 14:01:38 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894574
Page 140 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-06-2021 14:01:38 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894575
Page 141 of 223
***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, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-06-2021 13:59:40 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell  Approved Jan-27-2021 16:19:30 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, HayleneNell, 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 Dec-04-2020 13:29:33 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell  Approved Nov-17-2020 12:39:42 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, HayleneNell, 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.
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894576
Page 142 of 223
***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, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
 N/A Nov-16-2020 18:09:01 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell  Approved Nov-12-2020 21:11:10 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, HayleneNell, 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.
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894577
Page 143 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-08-2020 14:02:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-08-2020 14:02:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894578
Page 144 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-08-2020 14:03:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/8/2020Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894579
Page 145 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-08-2020 14:02:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12471226Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-08-2020 14:02:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1980Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-08-2020 14:03:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-08-2020 14:03:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-08-2020 14:03:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERICA
N
WHITEInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894580
Page 146 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 14:17:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894581
Page 147 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-08-2020 14:18:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020 14:18:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020 14:18:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894582
Page 148 of 223
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-08-2020 14:19:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Achalasia
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-08-2020 14:19:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-08-2020 14:19:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
AchalasiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-08-2020 14:19:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-08-2020 14:19:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894583
Page 149 of 223
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-24-2021 09:23:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Major depressive
disorder
Start Date: Apr/UNK/2020
Ongoing: YESInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894584
Page 150 of 223
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Feb-24-2021 09:23:25
(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
Mar-02-2021 16:43:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed closed based on site's
response
Mar-02-2021 08:47:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered NB Patient did not present
with Major depressive
disorder at entrance of
study. Depression was in
remission and it is a
resurgence. Patient did not
divulge his past event at
entrance of study. In the
opinion of the investigator
nothingposed a risk.
Feb-25-2021 23:04:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Reissued:Opened GPD Clin: Many thanks for
confirmation. Please add
violation of EC#1 into the
INCLUSION/EXCLUSION
CRITERIA eCRF page as
per section 8.6.2. of the
eCRF completion guide,
once CRF us unlocked.
Unlock request has been
posted.
Feb-24-2021 17:06:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Pt did not disclose
information at screening. Pt
will not be eligible for Vax
3
Feb-24-2021 13:09:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD CLIN: The subject
presents at screening with
Major depressive disorder.
Please confirm subject
meets eligibility per
exclusion criteria 1; else,
document deviation on I/E
CRF and report deviation as
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894585
Page 151 of 223
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
applicable. Thanks
Feb-24-2021 09:23:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Major depressive disorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Feb-24-2021 09:23:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Apr/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Feb-24-2021 09:23:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894586
Page 152 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-08-2020 14:19:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894587
Page 153 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-12-2020 20:38:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-12-2020 09:58:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Original value is
correct
Oct-09-2020 19:48:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
confirm subject's
weight is noted
correctly. Thank you.
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
45.1Initial Entry
3. Unit:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894588
Page 154 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15.6Initial Entry
7.a
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 35.8
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-09-2020 13:12:08
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-08-2020 14:34:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Original value is
correct
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 35.8 C
is outside of Normal
Range 36.1 - 37.5 C.
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
35.8Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894589
Page 155 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Unit:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-08-2020 14:19:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894590
Page 156 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-08-2020 14:20:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-08-2020 14:20:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
105052Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894591
Page 157 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 14:20:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 14:20:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 20:15:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 16:09:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-08-2020 14:20:22
(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-08-2020 14:20:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894592
Page 158 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-08-2020 20:15:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSTGBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 20:15:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSTGBInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020 20:16:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9CVFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 20:16:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9CVFInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 20:17:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSTGGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 20:17:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRSTGGInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894593
Page 159 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 14:20:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 14:20:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 20:14:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 16:09:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-08-2020 14:20:34
(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-08-2020 14:20:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894594
Page 160 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-08-2020 20:14:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9CVRInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 20:14:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9CVRInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894595
Page 161 of 223
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/8/2020 10:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894596
Page 162 of 223
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-08-2020 14:20:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894597
Page 163 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-17-2020 00:14:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-16-2020 18:09:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTPatient not part of
reactogenicity group,
however diary was
still collected
Nov-16-2020 13:05:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered DCF to be raised
Nov-15-2020 22:06:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Opened We checked within
TrialMax and a DCF
has not been issued,
Please review and
consider to update
response for
'Reactogenicity diary
collection' as 'Yes',
else clarify in query
response. Thanks.
Nov-10-2020 11:03:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Reissued:Candidate Awaiting TrialMax to
update.
Nov-09-2020 13:55:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Patient not part of
reactogenicity group;
diary activated in
error.
Nov-09-2020 12:52:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened eDiary: Per Trial
Max, Subject is the
subset of
'Reactogenicity Diary
collection'. Please
review and consider
to update response
for 'Reactogenicity
diary collection' as
'Yes', else clarify in
query response.
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894598
Page 164 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Thanks
Nov-06-2020 09:48:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTChanged Information
Oct-08-2020 14:21:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894599
Page 165 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 12:34:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894600
Page 166 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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-09-2020
10:36:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
ClosedData updated by site
Nov-06-2020
09:48:38
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
AnsweredData updated
Nov-06-2020
09:08:44
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
Reissued:
OpenedeDiary RQ1: Thanks
for your response.
Unfrozen per
response. Kindly
update the data.
Nov-05-2020
13:21:16
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
AnsweredPatient not part of
subset - please
unfreeze V1 for
updating. DCF to be
sent to trialmax
Nov-04-2020
10:55:20
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
Reissued:
OpenedDM:Vaccination is
given, however
FORM level
comment added as
NOT Applicable
added on
‘Vaccination
Symptoms Diary-
Symptom Resolved
Dates’ CRF. Please
review , as eDairy
data available in trail
max report else
clarify.
Nov-03-2020
13:46:02
(UTC+02:00)
Harare,ACV0PFEINFP6000  Query 1:
AnsweredPatient not part of
reactogenicity subset
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894601
Page 167 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria
Nov-03-2020
10:18:02
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW5242100;Were
medications to treat
fever/pain
given on the last day
the Subject
Diary was
completed? is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-02-2020
12:35:46
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
Nov-02-2020
12:35:38
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:Transcription Error
Nov-02-2020
12:35:11
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-02-2020 12:35:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FEV
ER
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FE
VEInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894602
Page 168 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:
2.a Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-05-2020
09:06:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedClosing as other query
issued for the same.
Nov-03-2020
13:46:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242124;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:35:20
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.b
Date Location User Value Reason
Nov-02-2020 12:36:12
(UTC+02:00) Harare,ACV0PFEINFP6000  Data Entry:
Symptom:: FATIInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894603
Page 169 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria GUE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cable
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UE
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894604
Page 170 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.b Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-10-2020
12:39:03
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedAs per site response
Nov-04-2020
11:39:41
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Reis
sued:C
andida
teRelated open query
present on 1 data point.
Nov-03-2020
13:46:25
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242125;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:36:12
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.c
Date Location User Value Reason
Nov-02-2020 12:36:22
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DACInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894605
Page 171 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
HE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cable
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894606
Page 172 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-10-2020
12:38:48
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedAs per site response
Nov-04-2020
11:38:48
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Reis
sued:C
andida
teRelated open query
present on 1 data point.
Nov-03-2020
13:46:35
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242126;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:36:22
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.d
Date Location User Value Reason
Nov-02-2020 12:36:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CHI
LLSInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894607
Page 173 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cable
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894608
Page 174 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.d Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-10-2020
12:39:17
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clo
sedAs per site response
Nov-04-2020
11:38:18
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Reis
sued:C
andida
teRelated open query
present on 1 data point.
Nov-03-2020
13:47:00
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242127;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:36:32
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.e
Date Location User Value Reason
Nov-02-2020 12:36:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VOM
ITINInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894609
Page 175 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
G
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appli
cable
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894610
Page 176 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-05-2020
08:36:34
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edResponse satisfies query
Nov-03-2020
13:47:09
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242115;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:36:42
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.f
Date Location User Value Reason
Nov-02-2020 12:36:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894611
Page 177 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Initial Entry
2.f Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-05-2020
09:06:46
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edClosing as other query
issued for the same.
Nov-03-2020
13:47:19
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242116;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:36:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.g
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894612
Page 178 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-02-2020 12:37:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Not Applic
ableInitial Entry
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Initial Entry
2.g Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020 20:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-09-2020 13:56:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Patient not part of
reactogenicity group.
V1 entry as NO
confirmed correct
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894613
Page 179 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-09-2020
13:46:55
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: V1 Reactogenicity
form is unfrozen. Please
update as appropriate.
Thanks
Nov-05-2020
13:19:33
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of subset -
please unfreeze V1 for
updating. DCF to be sent
to trialmax
Nov-04-2020
10:56:34
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Vaccination is given,
however FORM level
comment added as NOT
Applicable added on
‘Vaccination Symptoms
Diary- Symptom
Resolved Dates’ CRF.
Please review , as eDairy
data available in trail max
report else clarify.
Nov-03-2020
13:47:30
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5242117;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:37:04
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
2.h
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894614
Page 180 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-02-2020 12:37:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Not Appli
cableInitial Entry
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894615
Page 181 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.h Symptom:
Date Location User Value Reason
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020
12:37:08
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edAs per site response
Nov-04-2020
11:40:49
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Reis
sued:C
andida
teRelated open query
present on 1 data point.
Nov-03-2020
13:47:41
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:31:23
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242118;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-02-2020
12:37:14
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-02-2020 12:35:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894616
Page 182 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Nov-02-2020 12:37:24
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not
Appli
cableInitial Entry
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:Initial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-05-2020
07:53:11
(UTC+02:00)ACV0PFEINFP6000  Query
1: Clos
edResponse satisfies query
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894617
Page 183 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare,
Pretoria
Nov-03-2020
13:47:50
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:35:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242129;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-02-2020
12:37:24
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data E
ntry:
Not Ap
plicabl
eInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 12:37:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not A
pplica
bleInitial Entry
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894618
Page 184 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-05-2020
09:08:45
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edOther query issued for
the same.
Nov-03-2020
13:48:00
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:35:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242130;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-02-2020
12:37:34
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data E
ntry:
Not Ap
plicabl
eInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 12:37:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894619
Page 185 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Not App
licable
Nov-02-2020 12:35:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894620
Page 186 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-02-2020 12:35:11
(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-04-2020
11:02:05
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edOther query issued for
the same.
Nov-03-2020
13:48:10
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient not part of
reactogenicity subset
Nov-03-2020
10:35:36
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5242131;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-02-2020
12:37:46
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data E
ntry:
Not Ap
plicabl
eInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894621
Page 187 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2.a
Date Location User Value Reason
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894622
Page 188 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-02-2020 12:38:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894623
Page 189 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 12:38:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 12:38:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 12:39:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 12:38:47
(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.
Nov-02-2020 12:38:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 12:39:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BM9FMCInitial Entry
5.a Sample ID
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894624
Page 190 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-02-2020 12:39:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BM9FMCInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894625
Page 191 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Oct/30/2020 17:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894626
Page 192 of 223
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-02-2020 12:40:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894627
Page 193 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-09-2020 09:46:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-08-2020 11:50:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered EOT page updated
Dec-07-2020 12:31:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened DM: The treatment
period is defined as
1st vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT
to match date of visit
at visit 3.
Dec-04-2020 13:29:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894628
Page 194 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Dec-09-2020
07:57:24
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
ClosedNo eDairy Data in
DMW on
09DEC2020.
Dec-08-2020
11:40:49
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query 1:
AnsweredPatient did not
complete diary.
Patient not part of
reactogenicity group.
Diary activated in
error
Dec-07-2020
11:30:52
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW6319125;Were
medications to treat
fever/pain
given on the last day
the Subject
Diary was
completed? is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Dec-04-2020
13:30:44
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
2.a
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
eInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894629
Page 195 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
e
2.a Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-09-2020
07:57:35
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edNo eDairy Data in DMW
on 09DEC2020.
Dec-08-2020
11:41:55
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPatient did not complete
diary. Pt not part of
reactogenicity group.
Diary activated in error
Dec-07-2020
11:35:30
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW6319118;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
all symptoms and update
appropriately or clarify
Dec-04-2020
13:30:44
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
2.b
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
ApplInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894630
Page 196 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
e
2.b Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894631
Page 197 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894632
Page 198 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894633
Page 199 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.f Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894634
Page 200 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Appl
icabl
eInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
AppliInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894635
Page 201 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
cable
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:Not
Appli
cable
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-09-2020
07:57:52
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Clos
edNo eDairy Data in DMW
on 09DEC2020.
Dec-08-2020
11:42:53
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Query
1: Ans
weredPt not part of
reactogenicity group and
did not complete diary.
Diary activated in error
Dec-07-2020
11:42:20
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW6319155;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review all 3 Injection
Site Reaction and update
appropriately or clarify
Dec-04-2020
13:30:44
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000  Data E
ntry:
Not Ap
plicabl
eInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 13:30:44 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0894636
Page 202 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00) Harare,
PretoriaInjection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:Not
Appli
cable
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894637
Page 203 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-04-2020 13:30:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894638
Page 204 of 223
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020 13:30:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020 13:30:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 07:14:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-07-2020 07:08:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Dec-04-2020 13:30:26
(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.
Dec-04-2020 13:30:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894639
Page 205 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-07-2020 07:14:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BR7MSPInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 07:14:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BR7MSPInitial Entry
5.b
Date Location User Value Reason
Dec-07-2020 07:15:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRY9TGInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-07-2020 07:15:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRY9TGInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020 07:19:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRY9THInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-07-2020 07:19:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
BRY9THInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894640
Page 206 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894641
Page 207 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021 13:07:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 2: Closed Response satisfies
query
Feb-24-2021 09:32:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Answered Medical history page
has been updated
Feb-22-2021 22:02:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 2: Reissued:Opened GPD Clin: request
for unlock posted.
Thank you for
alerting in query
response once update
is made.
Feb-22-2021 12:29:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Answered Please unlock
medical history page
in order to update
data
Feb-19-2021 18:41:11
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 2: Opened GPD Clin: per the
SAE report
participant has
"known major
depressive disorder,
presented with
suicidal ideation with
a moderate risk
score". Can you
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894642
Page 208 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
please consider the
need to update MH
eCRF page
accordingly, else
clarify. Thanks
Feb-12-2021 19:38:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Feb-12-2021 12:44:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Answered Confirmed no past
medical history
according to source
notes
Feb-11-2021 18:27:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Please
confirm that this
participant does not
have a past medical
history of depression.
Currently Past Med
History CRF
contains no
conditions. Thank
you
Feb-10-2021 15:47:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Severe depressive episodeNew Information
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Hospitalization (Etiology to be conf
irmed)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Feb/4/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021 15:49:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/8/2021 UNK:UNKNew Information
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894643
Page 209 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-06-2021 13:59:40
(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).
Date Location User Value Reason
Feb-19-2021 09:43:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 3: Closed Updated to valid in
SDB
Feb-17-2021 08:26:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON: Event
was invalidated in
SDB. Please confirm
event seriousness.
Feb-12-2021 19:18:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 3: Reissued:Candidate Pending SDB update
Feb-11-2021 12:09:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 3: Answered SAE follow up report
was sent on 09 Feb
2021
Feb-11-2021 11:00:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 3: Opened SAE RECON:Severe
depressive
episode(Onset
date:04Feb2021) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894644
Page 210 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
on AE CRF
Feb-11-2021 10:59:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Closed new query issued
Feb-11-2021 10:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Feb-10-2021 22:15:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Reissued:Candidate Pending SDB update
Feb-10-2021 15:51:09
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Answered Term updated;
confirmed as SAE.
Follow up report sent
to Safety team on 09
Feb 2021
Feb-10-2021 15:47:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Severe
depressive episode:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-09-2021 19:10:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Query 2: Opened SAE RECON:
"Hospitalization
etiology to be
confirmed" has been
invalidated to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF.
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Hospitalization
(Etiology to be
confirmed): Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894645
Page 211 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Number" is blank.
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth def
ect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or p
rolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
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
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894646
Page 212 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-06-2021 13:59:40
(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:
Etiology to be confirmedInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021 15:51:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-10-2021 15:51:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-10-2021 15:49:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Severe
depressive episode:
Response to "What
was the outcome of
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894647
Page 213 of 223
***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, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
this adverse event?"
is 'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-06-2021 13:59:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-19-2021 09:43:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
2021122861Initial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894648
Page 214 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894649
Page 215 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-06-2021 14:00:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894650
Page 216 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-06-2021 14:00:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Feb-06-2021 14:00:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-06-2021 14:00:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
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).
Date Location User Value Reason
Feb-06-2021 14:00:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Feb-06-2021 14:00:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894651
Page 217 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
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).
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
Date Location User Value Reason
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894652
Page 218 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Feb-06-2021 14:00:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc7\Final\Final On: 01-Apr-2021 03:51 (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-2021-5683-0894653
Page 219 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-06-2021 14:01:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Rea
…[truncated]