Document text
Page 1 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893231
Page 2 of 328
***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: 12471135 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
Sep/30/2020
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893232
Page 3 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471135]
2.Birth Date: UNK/UNK/1951
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893233
Page 4 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893234
Page 5 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893235
Page 6 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893236
Page 7 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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:[Asthma]
Start Date: UNK/UNK/1991
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893237
Page 8 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893238
Page 9 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
2.Weight: [43.0]
3.Unit: kg
4.Height: [161.9]
5.Unit: cm
6.Body Mass Index: [16.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893239
Page 10 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893240
Page 11 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/30/2020
2.Randomization Number: [266614]
3.Randomization Group: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893241
Page 12 of 328
***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: 12471135 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:
Sep/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 [BM9CMM]
5.bSample ID [BRSF2X]
5.cSample ID [BRSF2Y]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893242
Page 13 of 328
***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: 12471135 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:
Sep/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 [BM9CMY]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893243
Page 14 of 328
***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: 12471135 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: Sep/30/2020 13:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893244
Page 15 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893245
Page 16 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893246
Page 17 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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 Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893247
Page 18 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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 Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893248
Page 19 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893249
Page 20 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893250
Page 21 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893251
Page 22 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893252
Page 23 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893253
Page 24 of 328
***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: 12471135 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
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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893254
Page 25 of 328
***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: 12471135 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: 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893255
Page 26 of 328
***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: 12471135 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:
Nov/23/2020
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 [BM9FTL]
5.bSample ID [BRY9KF]
5.cSample ID [BRY9KG]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893256
Page 27 of 328
***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: 12471135 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:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893257
Page 28 of 328
***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: 12471135 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: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893258
Page 29 of 328
***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: 12471135 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 [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893259
Page 30 of 328
***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: 12471135 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 [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893260
Page 31 of 328
***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: 12471135 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?
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893261
Page 32 of 328
***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: 12471135 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:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893262
Page 33 of 328
***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: 12471135 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:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893263
Page 34 of 328
***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: 12471135 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 [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893264
Page 35 of 328
***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: 12471135 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:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893265
Page 36 of 328
***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: 12471135 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 [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893266
Page 37 of 328
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893267
Page 38 of 328
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/18/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893268
Page 39 of 328
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/18/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/18/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Patient reported local injection site pain, No Covid illness suspected]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893269
Page 40 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Left Middle Cerebral Arter
y Infarct Oct/21/2020 UNK:
UNK YES Repeating
Pages
2.ADVERSE EV
ENT 2 Chronic cerebelar infarcts Oct/23/2020 11:34 YES Repeating
Pages
3.ADVERSE EV
ENT 3 Cerebral atrophy Oct/23/2020 11:34 YES Repeating
Pages
4.ADVERSE EV
ENT 4 Local injection site pain Feb/17/2021 UNK:
UNK YES Repeating
Pages
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893270
Page 41 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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)[Left Middle Cerebral Artery Infarct]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
YES
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:
[Pt.68 years old; and 50 pack year history of smoking as risk factors for event.]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893271
Page 42 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020413905]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893272
Page 43 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chronic cerebelar infarcts]
4.Start Date Time: Oct/23/2020 11:34
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CT finding]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893273
Page 44 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893274
Page 45 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cerebral atrophy]
4.Start Date Time: Oct/23/2020 11:34
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CT Findings]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893275
Page 46 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893276
Page 47 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Local injection site pain]
4.Start Date Time: Feb/17/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893277
Page 48 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893278
Page 49 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication Er
rorStart 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893279
Page 50 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893280
Page 51 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893281
Page 52 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893282
Page 53 of 328
***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: 12471135 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
ationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893283
Page 54 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893284
Page 55 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-spec
ifiedTreatment Start Date Form Instance
1.Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893285
Page 56 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893286
Page 57 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893287
Page 58 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893288
Page 59 of 328
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893289
Page 60 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893290
Page 61 of 328
***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: 12471135 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:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893291
Page 62 of 328
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893292
Page 63 of 328
***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: 12471135 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?
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893293
Page 64 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893294
Page 65 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893295
Page 66 of 328
***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: 12471135 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: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893296
Page 67 of 328
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893297
Page 68 of 328
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893298
Page 69 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893299
Page 70 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893300
Page 71 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893301
Page 72 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893302
Page 73 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/16/2021
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893303
Page 74 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893304
Page 75 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/16/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893305
Page 76 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893306
Page 77 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 12471135 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:
Feb/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKR5Y]
5.bSample ID [BRYB2J]
5.cSample ID [BRYB2K]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893307
Page 78 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12471135 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:
Feb/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKR5R]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893308
Page 79 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 10:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893309
Page 80 of 328
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893310
Page 81 of 328
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893311
Page 82 of 328
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12471135 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:
Mar/9/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKRBJ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893312
Page 83 of 328
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/9/2021 09:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893313
Page 84 of 328
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893314
Page 85 of 328
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893315
Page 86 of 328
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893316
Page 87 of 328
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893317
Page 88 of 328
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893318
Page 89 of 328
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893319
Page 90 of 328
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893320
Page 91 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/21/2020
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893321
Page 92 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893322
Page 93 of 328
***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: 12471135 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
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893323
FDA-CBER-2021-5683-0893324
FDA-CBER-2021-5683-0893325
FDA-CBER-2021-5683-0893326
FDA-CBER-2021-5683-0893327
FDA-CBER-2021-5683-0893328
FDA-CBER-2021-5683-0893329
FDA-CBER-2021-5683-0893330
FDA-CBER-2021-5683-0893331
FDA-CBER-2021-5683-0893332
FDA-CBER-2021-5683-0893333
Page 104 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:06:04 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment post SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893334
Page 105 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:06:04 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment post SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893335
Page 106 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-23-2020 11:06:04 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment post SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893336
Page 107 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893337
Page 108 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893338
Page 109 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893339
Page 110 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.bNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893340
Page 111 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.cNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893341
Page 112 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.dNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893342
Page 113 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.eNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893343
Page 114 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.fNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893344
Page 115 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.gNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893345
Page 116 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.hNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893346
Page 117 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893347
Page 118 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893348
Page 119 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893349
Page 120 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893350
Page 121 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-23-2020 11:06:52 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893351
Page 122 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:07:17 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893352
Page 123 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:07:17 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893353
Page 124 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-23-2020 11:07:17 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893354
Page 125 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-23-2020 11:07:17 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893355
Page 126 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-23-2020 11:07:17 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893356
Page 127 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893357
Page 128 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893358
Page 129 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893359
Page 130 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893360
Page 131 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893361
Page 132 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893362
Page 133 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893363
Page 134 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893364
Page 135 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-23-2020 11:07:37 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893365
Page 136 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:07:57 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893366
Page 137 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:07:57 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893367
Page 138 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-23-2020 11:07:57 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893368
Page 139 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-23-2020 11:07:57 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893369
Page 140 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-23-2020 11:07:57 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893370
Page 141 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893371
Page 142 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893372
Page 143 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893373
Page 144 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893374
Page 145 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893375
Page 146 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893376
Page 147 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893377
Page 148 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893378
Page 149 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893379
Page 150 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893380
Page 151 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893381
Page 152 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Nov-23-2020 11:08:15 (UTC+02:00) Harare,
PretoriaPatient discontinued treatment after SAE
Not Done
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893382
Page 153 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893383
Page 154 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893384
Page 155 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893385
Page 156 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.bNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893386
Page 157 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.cNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893387
Page 158 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.dNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893388
Page 159 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.eNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893389
Page 160 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.fNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893390
Page 161 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.gNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893391
Page 162 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.hNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893392
Page 163 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893393
Page 164 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893394
Page 165 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893395
Page 166 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893396
Page 167 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-23-2020 11:04:42 (UTC+02:00) Harare,
PretoriaPatient did not have vaccination Visit 2 due to
discontinuation post SAE
Not Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893397
Page 168 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893398
Page 169 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893399
Page 170 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893400
Page 171 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893401
Page 172 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893402
Page 173 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893403
Page 174 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893404
Page 175 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893405
Page 176 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893406
Page 177 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893407
Page 178 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Oct-22-2020 13:11:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893408
Page 179 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893409
Page 180 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893410
Page 181 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893411
Page 182 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893412
Page 183 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893413
Page 184 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
- Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-22-2020 13:11:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893414
Page 185 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893415
Page 186 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893416
Page 187 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893417
Page 188 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893418
Page 189 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893419
Page 190 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893420
Page 191 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893421
Page 192 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893422
Page 193 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893423
Page 194 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893424
Page 195 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Oct-22-2020 13:15:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893425
Page 196 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893426
Page 197 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893427
Page 198 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893428
Page 199 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893429
Page 200 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893430
Page 201 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893431
Page 202 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-22-2020 13:14:31 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893432
Page 203 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 13:14:56 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893433
Page 204 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 13:14:56 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893434
Page 205 of 328
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 13:14:56 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893435
Page 206 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-22-2021 11:23:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893436
Page 207 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-22-2021 11:23:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893437
Page 208 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-22-2021 11:23:58 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893438
Page 209 of 328
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - 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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-22-2021 11:23:58 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893439
Page 210 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-16-2021 12:29:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893440
Page 211 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-16-2021 12:32:55 (UTC+02:00) Harare,
PretoriaCOMMENT ENTERED IN ERROR
FormFeb-16-2021 12:31:28 (UTC+02:00) Harare,
PretoriaNOT APPLICABLE
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893441
Page 212 of 328
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-16-2021 12:32:06 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893442
Page 213 of 328
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-09-2021 09:11:54 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893443
Page 214 of 328
***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: 12471135 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-16-2021 09:51:48 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Jan-27-2021 14:57:26 (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 Nov-23-2020 11:03:56 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Nov-12-2020 15:34:14 (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.
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893444
Page 215 of 328
***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: 12471135 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
Sep-30-2020 13:30:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-30-2020 13:30:50
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893445
Page 216 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-30-2020 13:31:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/30/2020Initial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893446
Page 217 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-30-2020 13:30:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12471135Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-30-2020 13:30:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-30-2020 13:31:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-30-2020 13:31:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-30-2020 13:31:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fc4\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-2021-5683-0893447
Page 218 of 328
***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: 12471135 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-01-2020 06:58:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893448
Page 219 of 328
***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: 12471135 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-01-2020 06:59:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020 06:59:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020 06:59:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893449
Page 220 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-02-2020 07:29:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Asthma
Start Date: UNK/UNK/19
91
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-02-2020 07:29:27
(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-05-2020 08:17:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-05-2020 07:13:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered The participant is not
currently
receiving/plans to
receive systemic
corticosteroids with
the exception of
Inhaled Steroids due
to this condition.
Oct-02-2020 20:37:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: The
subject presents at
screening with
ongoing asthma.
Please confirm that
participant is or is not
currently
receiving/plans to
receive systemic
corticosteroids with
the exception of
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893450
Page 221 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Inhaled Steroids due
to this condition.
Oct-02-2020 07:29:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-02-2020 07:29:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-02-2020 07:29:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-02-2020 07:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Post Menopaus
al
Start Date: UNK/UNK/20
02
Ongoing: YESInitial Entry
090177e196ae2fc4\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-2021-5683-0893451
Page 222 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-02-2020 07:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 07:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Post MenopausalInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-02-2020 07:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-02-2020 07:29:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc4\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-2021-5683-0893452
Page 223 of 328
***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: 12471135 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-01-2020 07:00:38
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893453
Page 224 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
43.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
161.9Initial Entry
5. Unit:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16.4Initial Entry
7.a
090177e196ae2fc4\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-2021-5683-0893454
Page 225 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-01-2020 07:01:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fc4\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-2021-5683-0893455
Page 226 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sponsor-Defined Iden
tifier:Not Applica
bleInitial Entry
090177e196ae2fc4\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-2021-5683-0893456
Page 227 of 328
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-01-2020 07:01:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc4\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-2021-5683-0893457
Page 228 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-01-2020 07:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-01-2020 07:02:05
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
266614Initial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893458
Page 229 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 07:02:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 07:02:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:51:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 07:02:14
(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-01-2020 07:02:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:51:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9CMMInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893459
Page 230 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020 10:51:39
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9CMMInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 10:51:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSF2XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 10:51:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSF2XInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 10:52:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSF2YInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 10:52:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSF2YInitial Entry
090177e196ae2fc4\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-2021-5683-0893460
Page 231 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 07:02:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 07:02:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:51:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 07:02:23
(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-01-2020 07:02:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:51:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9CMYInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893461
Page 232 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020 10:51:20
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9CMYInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893462
Page 233 of 328
***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: 12471135 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-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sep/30/2020 13:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fc4\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-2021-5683-0893463
Page 234 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-01-2020 07:02:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893464
Page 235 of 328
***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: 12471135 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
Oct-01-2020 07:03:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893465
Page 236 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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-23-2020 11:06:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-23-2020 11:06:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893466
Page 237 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.b
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
neInitial Entry
090177e196ae2fc4\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-2021-5683-0893467
Page 238 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
ne
2.b Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.c
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
2.c Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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-2021-5683-0893468
Page 239 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.d
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.e
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
090177e196ae2fc4\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-2021-5683-0893469
Page 240 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.f
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
2.f Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.g
Date Location User Value Reason
Nov-23-2020 11:06:52 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fc4\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)
FDA-CBER-2021-5683-0893470
Page 241 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00) Harare,
PretoriaSymptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
ne
2.g Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.h
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:Not
Do
neInitial Entry
090177e196ae2fc4\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-2021-5683-0893471
Page 242 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.h Symptom:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Don
e
Were injection site reactions
present on the last day the Su
bject Diary was completed?:Not
Don
eInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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-2021-5683-0893472
Page 243 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Don
e
Were injection site reactions
present on the last day the Su
bject Diary was completed?:Not
Don
eInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Don
e
Were injection site reactions
present on the last day the Su
bject Diary was completed?:Not
Don
eInitial Entry
090177e196ae2fc4\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-2021-5683-0893473
Page 244 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:06:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893474
Page 245 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-23-2020 11:07:17
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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-2021-5683-0893475
Page 246 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893476
Page 247 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sponsor-Defined Identifi
er:Not Don
eInitial Entry
090177e196ae2fc4\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-2021-5683-0893477
Page 248 of 328
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Test:: Not Don
e
Result:: Not Don
e
Not Done:: Not Don
e
6.a Sponsor ID:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-23-2020 11:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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-2021-5683-0893478
Page 249 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 11:07:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 11:07:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 11:07:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-23-2020 11:07:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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)
FDA-CBER-2021-5683-0893479
Page 250 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 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-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
090177e196ae2fc4\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-2021-5683-0893480
Page 251 of 328
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-23-2020 11:08:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fc4\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-2021-5683-0893481
Page 252 of 328
***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: 12471135 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-23-2020 11:03:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/23/2020Initial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893482
Page 253 of 328
***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: 12471135 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-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.b
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cableInitial Entry
090177e196ae2fc4\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-2021-5683-0893483
Page 254 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cable
2.b Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.c
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
2.c Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc4\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-2021-5683-0893484
Page 255 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.d
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.e
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
090177e196ae2fc4\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-2021-5683-0893485
Page 256 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.f
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
2.f Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.g
Date Location User Value Reason
Nov-23-2020 11:04:42 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fc4\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)
FDA-CBER-2021-5683-0893486
Page 257 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00) Harare,
PretoriaSymptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cable
2.g Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.h
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:Not
Appli
cableInitial Entry
090177e196ae2fc4\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-2021-5683-0893487
Page 258 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.h Symptom:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:Not
Appli
cableInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:04:42 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fc4\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)
FDA-CBER-2021-5683-0893488
Page 259 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00) Harare,
PretoriaNot Applicable
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:Not
Appli
cableInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cableInitial Entry
090177e196ae2fc4\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-2021-5683-0893489
Page 260 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:Not
Appli
cable
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:04:42
(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
Nov-23-2020 11:04:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc4\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893490
Page 261 of 328
***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: 12471135 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 11:05:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto c
…[truncated]