Document text
Page 1 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891810
Page 2 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/28/2020
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891811
Page 3 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471066]
2.Birth Date: UNK/UNK/1962
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891812
Page 4 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891813
Page 5 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891814
Page 6 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891815
Page 7 of 514
***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: 12471066 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:[Post Menopausal]
Start Date: UNK/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral tubal ligation]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891816
Page 8 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891817
Page 9 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
2.Weight: [95.0]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [37.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891818
Page 10 of 514
***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: 12471066 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: Sep/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891819
Page 11 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/29/2020
2.Randomization Number: [266464]
3.Randomization Group: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891820
Page 12 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BM9CHB]
5.bSample ID [BRSDYF]
5.cSample ID [BRSDYG]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891821
Page 13 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BM9CH6]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891822
Page 14 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 08:56
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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891823
Page 15 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891824
Page 16 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891825
Page 17 of 514
***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: 12471066 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891826
Page 18 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891827
Page 19 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891828
Page 20 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891829
Page 21 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Patient not receiving Vax 2 after positve swab test] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891830
Page 22 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891831
Page 23 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891832
Page 24 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891833
Page 25 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891834
Page 26 of 514
***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, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Convalescent visit and Visit 3 occurred on same day. Samples collected captured at
convalescent visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]Comments
5.bSample ID Not Done
[ ]Comments
5.cSample ID Not Done
[ ]Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891835
Page 27 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891836
Page 28 of 514
***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891837
Page 29 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891838
Page 30 of 514
***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891839
Page 31 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891840
Page 32 of 514
***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891841
Page 33 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891842
Page 34 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/16/2020
2.Date of First Symptom Started: Oct/15/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891843
Page 35 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.Symptoms - Other Text: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891844
Page 36 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of C
ollectionSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Description Device TypeForm Instan
ce
1. DELETED SWABBED
MATERIAL NASOPHARY
NX Repeating
Pages
2. Oct/23/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891845
Page 37 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [details of swab will be confirmed ]
9.Trade Name Other, Specify: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891846
Page 38 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/23/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [Covid Illness confirmed by positive SARS_CoV_2 PCR test done at the National
Health Laboratory Services in Cape Town South Africa]
9.Trade Name Other, Specify: [CLIA-certified lab]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891847
Page 39 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12471066 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV23918]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891848
Page 40 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab performed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891849
Page 41 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[7]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891850
Page 42 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891851
Page 43 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Oct/23/2020 NO
Discharge Date:
Oct/26/2020
Repeating Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891852
Page 44 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Oct/23/2020
4.Ongoing? NO
Discharge Date:
Oct/26/2020
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891853
Page 45 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Oct/23/2
020 Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891854
Page 46 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1] Comments
2.Concomitant Non-drug Treatment
Pre-specified:YES Comments
3.Treatment: HIGH FLOW OXYGEN THERAPY Comments
4.Treatment: [HIGH FLOW OXYGEN THERAPY] Comments
5.Start Date: Oct/23/2020 Comments
6.Ongoing? NO
End Date:
Oct/24/2020Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891855
Page 47 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Oct/23/2020
3.Toxicity Grade: 3
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891856
Page 48 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891857
Page 49 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891858
Page 50 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for L
ab TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891859
Page 51 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891860
Page 52 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891861
Page 53 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891862
Page 54 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891863
Page 55 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891864
Page 56 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891865
Page 57 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891866
Page 58 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891867
Page 59 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891868
Page 60 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891869
Page 61 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891870
Page 62 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0891871
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891872
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891873
Page 65 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891874
Page 66 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891875
Page 67 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891876
Page 68 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891877
Page 69 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891878
Page 70 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891879
Page 71 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891880
Page 72 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/16/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891881
Page 73 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/16/2020Form: 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: 12471066 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/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9FR7]
5.bSample ID [BRSTMD]
5.cSample ID [BRSTMF]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891882
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***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: 12471066 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:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891883
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***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891884
Page 76 of 514
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891885
Page 77 of 514
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891886
Page 78 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Identifie
rAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1. DELETED Not Applicab
le Not Applicab
le Not Applicab
le Not Applicab
le Not Applicable Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891887
Page 79 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: Not Applicable Comments
2.AE ID: Not Applicable
[ ]Comments
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)Not Applicable
[ ]Comments
4.Start Date Time: Not Applicable
//Comments
5.Is the adverse event still ongoing? Not Applicable Comments
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).Not Applicable Comments
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.Not Applicable Comments
9.Is this event related to study
treatment:Not Applicable Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891888
Page 80 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:Not Applicable Comments
11.Was a Concomitant Medication
given?Not Applicable Comments
12.Was a Non-Drug Treatment given? Not Applicable Comments
13.What was the outcome of this
adverse event?:Not Applicable Comments
14.Did the adverse event cause the
subject to be discontinued from the
study?Not Applicable Comments
15.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891889
Page 81 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891890
Page 82 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891891
Page 83 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891892
Page 84 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891893
Page 85 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. DELETED Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891894
Page 86 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Locked, Frozen,
Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ] Comments
2.Category: Comments
3.Concomitant Medications
Pre-specified: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).[ ] Comments
5.Dose: [ ] Comments
6.Dose Unit: Comments
7.Dose Frequency: Comments
8.Route: Comments
9.Start Date: // Comments
10.Ongoing? Comments
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891895
Page 87 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891896
Page 88 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891897
Page 89 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891898
Page 90 of 514
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891899
Page 91 of 514
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Patient tested positive for COVID 19 and was symptomatic prior to visit 2]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891900
Page 92 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891901
Page 93 of 514
***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: 12471066 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:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891902
Page 94 of 514
***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: 12471066 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:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891903
Page 95 of 514
***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: 12471066 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?
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891904
Page 96 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891905
Page 97 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891906
Page 98 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891907
Page 99 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891908
Page 100 of 514
***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891909
Page 101 of 514
***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: 12471066 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 [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891910
Page 102 of 514
***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: 12471066 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: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891911
Page 103 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891912
Page 104 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891913
Page 105 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891914
Page 106 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891915
Page 107 of 514
***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: 12471066 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
[ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891916
Page 108 of 514
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891917
Page 109 of 514
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891918
Page 110 of 514
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891919
Page 111 of 514
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891920
Page 112 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/15/2020
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891921
Page 113 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891922
Page 114 of 514
***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: 12471066 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
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891923
Page 115 of 514
***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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-28-2020 14:34:35 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891924
Page 116 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-11-2020 08:16:06 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891925
Page 117 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-11-2020 08:16:06 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891926
Page 118 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-11-2020 08:16:06 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891927
Page 119 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-11-2020 08:16:06 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891928
Page 120 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-11-2020 08:16:06 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891929
Page 121 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891930
Page 122 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891931
Page 123 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891932
Page 124 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891933
Page 125 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891934
Page 126 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891935
Page 127 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891936
Page 128 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891937
Page 129 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-11-2020 08:16:43 (UTC+02:00) Harare,
PretoriaPatient not receivng Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891938
Page 130 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 07:32:10 (UTC+02:00) Harare,
Pretoria
FormNov-11-2020 08:17:24 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891939
Page 131 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 07:32:10 (UTC+02:00) Harare,
Pretoria
1Nov-11-2020 08:17:24 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891940
Page 132 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 07:32:10 (UTC+02:00) Harare,
Pretoria
2Nov-11-2020 08:17:24 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891941
Page 133 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 07:32:10 (UTC+02:00) Harare,
Pretoria
3Nov-11-2020 08:17:24 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891942
Page 134 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 07:32:10 (UTC+02:00) Harare,
Pretoria
4Nov-11-2020 08:17:24 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891943
Page 135 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891944
Page 136 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891945
Page 137 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891946
Page 138 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891947
Page 139 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
4Oct-29-2020 07:43:06 (UTC+02:00) Harare,
PretoriaThis visit is delayed due to the use corticosteroids.
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891948
Page 140 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891949
Page 141 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891950
Page 142 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891951
Page 143 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891952
Page 144 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891953
Page 145 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891954
Page 146 of 514
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Nov-11-2020 08:14:56 (UTC+02:00) Harare,
PretoriaPatient not receiving Vax 2
Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891955
Page 147 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891956
Page 148 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891957
Page 149 of 514
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Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891958
Page 150 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.bNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891959
Page 151 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.cNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891960
Page 152 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.dNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891961
Page 153 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.eNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891962
Page 154 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2 fNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891963
Page 155 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.gNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891964
Page 156 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2 hNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891965
Page 157 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891966
Page 158 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891967
Page 159 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891968
Page 160 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891969
Page 161 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-16-2020 09:37:00 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891970
Page 162 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aFeb-12-2021 07:32:16 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891971
Page 163 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bFeb-12-2021 07:32:29 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891972
Page 164 of 514
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cFeb-12-2021 07:32:43 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891973
Page 165 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
FormOct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891974
Page 166 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
1Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891975
Page 167 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
2Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891976
Page 168 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
3Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891977
Page 169 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
4Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891978
Page 170 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
5Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891979
Page 171 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Mar-08-2021 15:08:31 (UTC+02:00) Harare,
Pretoria
6Oct-20-2020 16:34:21 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891980
Page 172 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-24-2020 10:51:10 (UTC+02:00) Harare,
PretoriaNot Applicable
FormOct-24-2020 10:48:12 (UTC+02:00) Harare,
Pretoria
FormOct-20-2020 16:36:58 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891981
Page 173 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-24-2020 10:51:10 (UTC+02:00) Harare,
PretoriaNot Applicable
1Oct-24-2020 10:48:12 (UTC+02:00) Harare,
Pretoria
1Oct-20-2020 16:36:58 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891982
Page 174 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-24-2020 10:51:10 (UTC+02:00) Harare,
PretoriaNot Applicable
2Oct-24-2020 10:48:12 (UTC+02:00) Harare,
Pretoria
2Oct-20-2020 16:36:58 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891983
Page 175 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-24-2020 10:51:10 (UTC+02:00) Harare,
PretoriaNot Applicable
3Oct-24-2020 10:48:12 (UTC+02:00) Harare,
Pretoria
3Oct-20-2020 16:36:58 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891984
Page 176 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-24-2020 10:51:10 (UTC+02:00) Harare,
PretoriaNot Applicable
4Oct-24-2020 10:48:12 (UTC+02:00) Harare,
Pretoria
4Oct-20-2020 16:36:58 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891985
Page 177 of 514
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
2Oct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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3Oct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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4Oct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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5.aOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5.aOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.aOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.aOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.bOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.bOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.bOct-20-2020 16:37:13 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.dOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.dOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.dOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.eOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.eOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 16:37:13 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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FDA-CBER-2021-5683-0892017
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Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Subject No: 12471066 Subject Initials: ---
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
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Subject No: 12471066 Subject Initials: ---
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Subject No: 12471066 Subject Initials: ---
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Subject No: 12471066 Subject Initials: ---
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5 fOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5 fOct-20-2020 16:37:41 (UTC+02:00) Harare,
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5 fOct-20-2020 16:37:41 (UTC+02:00) Harare,
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5 fOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
5.gOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.gOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Subject No: 12471066 Subject Initials: ---
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PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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5.gOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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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: 12471066 Subject Initials: ---
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5 hOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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5 hOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
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Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5 hOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.iOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.iOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.iOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.iOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.jOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.jOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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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: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.jOct-20-2020 16:37:41 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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***Confidential***
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 16:38:06 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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***Confidential***
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
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ItemDate User Comment
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PretoriaHaylene Nell Not Applicable
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***Confidential***
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 16:38:23 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 16:38:23 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 16:38:38 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Page 266 of 514
***Confidential***
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Oct/16/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 16:38:38 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Oct/16/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 16:38:38 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Page 270 of 514
***Confidential***
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Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Page 271 of 514
***Confidential***
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Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Page 272 of 514
***Confidential***
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Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Page 273 of 514
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-20-2020 16:39:05 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 16:39:48 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 16:39:48 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 16:39:48 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 16:39:48 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 16:39:48 (UTC+02:00) Harare,
PretoriaHaylene Nell Not Applicable
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
FormOct-29-2020 09:22:43 (UTC+02:00) Harare,
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090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
1Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
2Oct-29-2020 09:22:43 (UTC+02:00) Harare,
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
3Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
6Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
7Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
8Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
9Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
10Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
11Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
12Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
13Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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FDA-CBER-2021-5683-0892102
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
14Oct-29-2020 09:22:43 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc1\Final\Final On: 01-Apr-2021 03:50 (GMT)
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***Confidential***
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Form Version: 22-Apr-2020 21:02 Form
…[truncated]