Document text
Page 1 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893816
Page 2 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/5/2020
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893817
Page 3 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471172]
2.Birth Date: UNK/UNK/1981
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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893818
Page 4 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893819
Page 5 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893820
Page 6 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893821
Page 7 of 195
***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: 12471172 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:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893822
Page 8 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893823
Page 9 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
2.Weight: [85.0]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [30.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893824
Page 10 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893825
Page 11 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/5/2020
2.Randomization Number: [103606]
3.Randomization Group: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893826
Page 12 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BM9CS3]
5.bSample ID [BRSTC2]
5.cSample ID [BRSTC4]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893827
Page 13 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BM9CR3]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893828
Page 14 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/5/2020 12:12
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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893829
Page 15 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893830
Page 16 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893831
Page 17 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/11/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893832
Page 18 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893833
Page 19 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893834
Page 20 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/26/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893835
Page 21 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BM9FJK]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893836
Page 22 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/26/2020 10:58
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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893837
Page 23 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893838
Page 24 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893839
Page 25 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893840
Page 26 of 195
***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: 12471172 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 [BM9FV0]
5.bSample ID [BRY9L7]
5.cSample ID [BRY9L8]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893841
Page 27 of 195
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893842
Page 28 of 195
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893843
Page 29 of 195
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893844
Page 30 of 195
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893845
Page 31 of 195
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893846
Page 32 of 195
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893847
Page 33 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893848
Page 34 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12471172 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: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893849
Page 35 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893850
Page 36 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893851
Page 37 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12471172 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?
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893852
Page 38 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893853
Page 39 of 195
***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: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893854
Page 40 of 195
***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: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893855
Page 41 of 195
***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: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893856
Page 42 of 195
***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: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893857
Page 43 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893858
Page 44 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: UNPLANNED VISIT
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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893859
Page 45 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471172 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:
Oct/28/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893860
Page 46 of 195
***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: 12471172 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 axilla Lymphade
nopathy Oct/27/2020 UNK
:UNK NO
End Date Time:
Nov/4/2020 UNK:UNK
Repeating
Pages
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893861
Page 47 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12471172 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 axilla Lymphadenopathy]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/4/2020 UNK:UNK
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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893862
Page 48 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893863
Page 49 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893864
Page 50 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893865
Page 51 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893866
Page 52 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893867
Page 53 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applica
ble Repeating
Pages
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893868
Page 54 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893869
Page 55 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893870
Page 56 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893871
Page 57 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893872
Page 58 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893873
Page 59 of 195
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893874
Page 60 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893875
Page 61 of 195
***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: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893876
Page 62 of 195
***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: 12471172 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:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893877
Page 63 of 195
***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: 12471172 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?
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893878
Page 64 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893879
Page 65 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893880
Page 66 of 195
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893881
Page 67 of 195
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893882
Page 68 of 195
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893883
Page 69 of 195
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893884
Page 70 of 195
***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: 12471172 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: [ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893885
Page 71 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893886
Page 72 of 195
***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
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893887
Page 73 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893888
Page 74 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893889
Page 75 of 195
***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: 12471172 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
[ ]
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893890
Page 76 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/23/2020
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893891
Page 77 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893892
Page 78 of 195
***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: 12471172 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
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893893
Page 79 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-05-2020 16:56:51 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893894
Page 80 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893895
Page 81 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893896
Page 82 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893897
Page 83 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893898
Page 84 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893899
Page 85 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893900
Page 86 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893901
Page 87 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893902
Page 88 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893903
Page 89 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893904
Page 90 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-24-2020 15:01:34 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893905
Page 91 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893906
Page 92 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893907
Page 93 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893908
Page 94 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893909
Page 95 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893910
Page 96 of 195
***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, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-24-2020 15:02:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893911
Page 97 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893912
Page 98 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893913
Page 99 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893914
Page 100 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893915
Page 101 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893916
Page 102 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893917
Page 103 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893918
Page 104 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893919
Page 105 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893920
Page 106 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893921
Page 107 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-24-2020 15:02:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893922
Page 108 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0893923
Page 109 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893924
Page 110 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893925
Page 111 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893926
Page 112 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893927
Page 113 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893928
Page 114 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-24-2020 15:03:41 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893929
Page 115 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-24-2020 15:04:13 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893930
Page 116 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-24-2020 15:04:13 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893931
Page 117 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-24-2020 15:04:13 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893932
Page 118 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-23-2021 11:56:17 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893933
Page 119 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-23-2021 11:56:17 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893934
Page 120 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-23-2021 11:56:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893935
Page 121 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-23-2021 11:56:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893936
Page 122 of 195
***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: 12471172 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-23-2021 11:55:16 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Jan-27-2021 16:24:28 (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 10:31:47 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Nov-12-2020 19:14:24 (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.
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893937
Page 123 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-05-2020 12:27:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-05-2020 12:27:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893938
Page 124 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-05-2020 12:28:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/5/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0893939
Page 125 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-05-2020 12:27:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12471172Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-05-2020 12:27:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1981Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-05-2020 12:30:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-05-2020 12:30:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-05-2020 12:30:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fc8\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-2021-5683-0893940
Page 126 of 195
***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: 12471172 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-05-2020 16:56:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893941
Page 127 of 195
***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: 12471172 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-05-2020 16:57:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-05-2020 16:57:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020 16:57:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893942
Page 128 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-05-2020 16:57:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Hypertension
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-05-2020 16:57:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-05-2020 16:57:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-05-2020 16:57:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-05-2020 16:57:49
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc8\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-2021-5683-0893943
Page 129 of 195
***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: 12471172 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-05-2020 16:58:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893944
Page 130 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
85.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.1Initial Entry
090177e196ae2fc8\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-2021-5683-0893945
Page 131 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-05-2020 16:58:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fc8\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-2021-5683-0893946
Page 132 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin 113Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893947
Page 133 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria ed Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-05-2020 16:59:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893948
Page 134 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-05-2020 16:59:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-05-2020 16:59:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
103606Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893949
Page 135 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 16:59:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 16:59:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 22:12:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 16:59:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-05-2020 16:59:32
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 22:12:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9CS3Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893950
Page 136 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 22:12:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9CS3Initial Entry
5.b
Date Location User Value Reason
Oct-05-2020 22:12:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSTC2Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 22:12:33
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSTC2Initial Entry
5.c
Date Location User Value Reason
Oct-05-2020 22:12:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRSTC4Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 22:12:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRSTC4Initial Entry
090177e196ae2fc8\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-2021-5683-0893951
Page 137 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 16:59:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 16:59:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 22:12:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 16:59:42
(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-05-2020 16:59:42
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 22:12:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9CR3Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893952
Page 138 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 22:12:01
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9CR3Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893953
Page 139 of 195
***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: 12471172 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-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/5/2020 12:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fc8\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-2021-5683-0893954
Page 140 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-05-2020 17:00:14
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893955
Page 141 of 195
***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: 12471172 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-05-2020 17:00:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893956
Page 142 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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-26-2020 13:50:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893957
Page 143 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-28-2020 15:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GUTranscription Error
090177e196ae2fc8\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-2021-5683-0893958
Page 144 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FATIGUE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:YES
Ongoing
?
NO
Stop
Date:
Oct
/11/
202
0Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893959
Page 145 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.b Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-30-2020 09:38:48
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 15:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-28-2020 15:07:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOTranscription Error
Oct-28-2020 12:14:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened eDiary: Per diary
records, FATIGUE
not present on Last
day however inform
is entered with 'Yes'
for the same. Please
verify and update.
Else, clarify. Thanks
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/11/2020Initial Entry
2.c
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fc8\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-2021-5683-0893960
Page 146 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria Symptom:: HEADA
CHE
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:YES
Ongoing
?
NO
Stop
Date:
Oct
/11/
202
0
2.c Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/11/2020Initial Entry
2.d
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LSInitial Entry
090177e196ae2fc8\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-2021-5683-0893961
Page 147 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.d Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893962
Page 148 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
090177e196ae2fc8\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-2021-5683-0893963
Page 149 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893964
Page 150 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.h Symptom:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2fc8\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-2021-5683-0893965
Page 151 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction PAIN AInitial Entry
090177e196ae2fc8\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-2021-5683-0893966
Page 152 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
:: T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-27-2020 15:05:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893967
Page 153 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
2.a
Date Location User Value Reason
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fc8\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-2021-5683-0893968
Page 154 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-26-2020 13:52:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893969
Page 155 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin 113Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893970
Page 156 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria ed Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-26-2020 13:54:30
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893971
Page 157 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 13:54:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 13:54:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 14:54:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-27-2020 10:42:06
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-26-2020 13:54:40
(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-26-2020 13:54:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893972
Page 158 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-27-2020 14:54:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9FJKInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 14:54:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9FJKInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893973
Page 159 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-30-2020
07:53:56
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query 1
: Closedupdated
Oct-29-2020
12:04:56
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Haylene Nell Query 1
: Answe
redSubject was
contacted on 28 Oct
2020. Visit will be
updated.
Oct-29-2020
08:37:50
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPDQ: Subject has
reported with
Severe
symptoms/reactions
on '2020-10-27'.
Per protocol,
subjects
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893974
Page 160 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
experiencing Grade
3 local reactions
should be
contacted. Please
confirm if an
UNPLANNED
CONTACT was
made and update
the corresponding
form as appropriate.
Oct-26-2020
13:55:29
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data E
ntry:
Oct/26/
2020 10
:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893975
Page 161 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria SERVATION PERIOD
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-26-2020 13:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893976
Page 162 of 195
***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: 12471172 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 10:31:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/23/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893977
Page 163 of 195
***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: 12471172 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 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae2fc8\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-2021-5683-0893978
Page 164 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893979
Page 165 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2fc8\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-2021-5683-0893980
Page 166 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893981
Page 167 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.f Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893982
Page 168 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.h
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
090177e196ae2fc8\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-2021-5683-0893983
Page 169 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complet
ed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893984
Page 170 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 10:32:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893985
Page 171 of 195
***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: 12471172 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 10:34:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 10:34:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 07:57:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-23-2020 13:33:56
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 10:34:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 10:34:43
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/23/2020Initial Entry
5.a
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893986
Page 172 of 195
***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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-24-2020 07:57:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BM9FV0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020 07:57:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BM9FV0Initial Entry
5.b
Date Location User Value Reason
Nov-24-2020 07:58:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRY9L7Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020 07:58:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRY9L7Initial Entry
5.c
Date Location User Value Reason
Nov-24-2020 07:58:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Sample ID: BRY9L8Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-24-2020 07:58:58
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
BRY9L8Initial Entry
090177e196ae2fc8\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-2021-5683-0893987
Page 173 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: 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: 12471172 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-29-2020 10:20:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Haylene Nell Data Entry:
Oct/28/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893988
Page 174 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: UNPLANNED VISIT - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Assessments
Date Location User Value Reason
Oct-29-2020 10:22:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 10:21:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update
as appropriate.
Oct-29-2020 10:21:02
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Haylene Nell Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893989
Page 175 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/28/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-29-2020 10:21:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Oct-29-2020 10:22:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 10:22:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Haylene Nell Data Entry:
YES
Date of Contact:
Oct/28/2020
Contact Outcome:
VISIT NOT REQUIRED, IN
VESTIGATOR DECISIONTranscription Error
Oct-29-2020 10:21:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date
of Contact" is
missing.
Oct-29-2020 10:21:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Haylene Nell Data Entry:
YES
Contact Outcome:
VISIT NOT REQUIRED, IN
VESTIGATOR DECISIONInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893990
Page 176 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Form Created
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893991
Page 177 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Left axilla LymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/4/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fc8\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-2021-5683-0893992
Page 178 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893993
Page 179 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pretoria
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020 11:11:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fc8\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-2021-5683-0893994
Page 180 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\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-2021-5683-0893995
Page 181 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-24-2020 15:01:34
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\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-2021-5683-0893996
Page 182 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 15:02:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 15:02:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 15:02:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Nov-24-2020 15:02:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Nov-24-2020 15:02:00
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\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-2021-5683-0893997
Page 183 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
090177e196ae2fc8\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-2021-5683-0893998
Page 184 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Nov-24-2020 15:02:28
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\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-2021-5683-0893999
Page 185 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Nov-24-2020 15:03:41
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\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-2021-5683-0894000
Page 186 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Nov-24-2020 15:04:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Nov-24-2020 15:04:13
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894001
Page 187 of 195
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 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
Nov-23-2020 10:34:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Nov/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-23-2020 10:34:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-23-2020 10:34:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894002
Page 188 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 11:55:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894003
Page 189 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 16:44:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Changed
Information
Feb-23-2021 11:55:29
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894004
Page 190 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021 11:56:04
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-25-2021
03:55:46
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-24-2021
16:46:51
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Query
1: An
swere
d"Participant is willing
to return" is selected
Feb-24-2021
12:34:19
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7399242;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-23-2021
11:56:04
(UTC+02:00)
Harare,
PretoriaACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITYInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894005
Page 191 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894006
Page 192 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-23-2021 11:56:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894007
Page 193 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-23-2021 11:56:36
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894008
Page 194 of 195
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-23-2020 10:34:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-05-2020 16:59:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-05-2020 16:57:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-23-2020 10:34:57
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/23/2020Initial Entry
Oct-05-2020 16:59:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Oct-05-2020 16:57:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894009
Page 195 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-11-2020 12:09:07
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fc8\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894010