Document text
Page 1 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821061
Page 2 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/6/2020
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821062
Page 3 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12131049]
2.Birth Date: 1958
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821063
Page 4 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821064
Page 5 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821065
Page 6 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathNov/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821066
Page 7 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type-2 Diabetes Mellitus]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821067
Page 8 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821068
Page 9 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
2.Weight: [92.0]
3.Unit: kg
4.Height: [176.0]
5.Unit: cm
6.Body Mass Index: [29.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821069
Page 10 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/6/2020
2.Randomization Number: [274103]
3.Randomization Group: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821070
Page 11 of 156
***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, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BPZCV8]
5.bSample ID [BPZCV9]
5.cSample ID [BSHCKM]
5.dSample ID [BSHCKN]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821071
Page 12 of 156
***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, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BPZCV7]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821072
Page 13 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Nov/6/2020 11:40
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821073
Page 14 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821074
Page 15 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/27/2020
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821075
Page 16 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821076
Page 17 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821077
Page 18 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821078
Page 19 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/27/2020
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 [BPZCXY]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821079
Page 20 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Nov/27/2020 11:07
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821080
Page 21 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/25/2020
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821081
Page 22 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821082
Page 23 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
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
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821083
Page 24 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/25/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8M88]
5.bSample ID [BN8M89]
5.cSample ID [BSHCSK]
5.dSample ID [BSHCSL]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821084
Page 25 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821085
Page 26 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821086
Page 27 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821087
Page 28 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821088
Page 29 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821089
Page 30 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821090
Page 31 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821091
Page 32 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821092
Page 33 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821093
Page 34 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821094
Page 35 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821095
Page 36 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821096
Page 37 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821097
Page 38 of 156
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821098
Page 39 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821099
Page 40 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821100
Page 41 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 Hypertensive crisis Nov/24/202
0 21:30 NO
End Date Time:
Nov/25/2020 22:00
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 Worsening Hyperte
nsion Attack Nov/24/202
0 21:30 NO
End Date Time:
Nov/25/2020 22:00
Repeating
Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821101
Page 42 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hypertensive crisis]
4.Start Date Time: Nov/24/2020 21:30
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/25/2020 22:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821102
Page 43 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hypertensive urgency]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020470878]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821103
Page 44 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening Hypertension Attack ]
4.Start Date Time: Nov/24/2020 21:30
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/25/2020 22:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821104
Page 45 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hypertension ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020470878 ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821105
Page 46 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821106
Page 47 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821107
Page 48 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821108
Page 49 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821109
Page 50 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821110
Page 51 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821111
Page 52 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821112
Page 53 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821113
Page 54 of 156
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821114
Page 55 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821115
Page 56 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821116
Page 57 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821117
Page 58 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821118
Page 59 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821119
Page 60 of 156
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821120
Page 61 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821121
Page 62 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821122
Page 63 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821123
Page 64 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821124
Page 65 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821125
Page 66 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821126
Page 67 of 156
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821127
Page 68 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821128
Page 69 of 156
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821129
Page 70 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821130
Page 71 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821131
Page 72 of 156
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821132
Page 73 of 156
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821133
Page 74 of 156
***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: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/25/2020
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821134
Page 75 of 156
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821135
Page 76 of 156
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Omer Tabak Approved Jan-21-2021 16:04:59 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, OmerTabak, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821136
Page 77 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-06-2020 16:33:12 (UTC+03:00)
IstanbulNot Applicable
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821137
Page 78 of 156
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Omer Tabak Approved Jan-21-2021 16:04:59 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, OmerTabak, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-08-2020 17:30:05 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Omer Tabak Approved Dec-02-2020 17:23:46 (UTC+03:00)
IstanbulBOOK Signed
Affidavit:
By my dated signature below, I, OmerTabak, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821138
Page 79 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-06-2020 16:32:02
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-06-2020 16:32:02
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821139
Page 80 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-06-2020 16:32:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Nov/6/2020Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821140
Page 81 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-02-2020
10:51:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-02-2020
10:50:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies query
Dec-02-2020
10:44:28
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered updated.
Dec-02-2020
10:44:28
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
12131049updated.
Dec-02-2020
10:44:02
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Answered AE CRF page updated.
Dec-02-2020
10:29:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Reissued:Ope
nedSAE RECON 1: SAE
Hypertension attack still
missing in AE CRF. Please
check and update CRF.
Dec-02-2020
10:28:32
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Reissued:Ope
nedSAE RECON 1: Event
chest pain still missing in
AE CRF. Please check AE
page, the verbatim reported
is '2020470878'
Dec-01-2020
16:37:41
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Answered SAE form for chest pain
was completed and sent
sponsor on 27Nov2020.
AE CRF page was updated
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821141
Page 82 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
for this SAE:
Dec-01-2020
16:15:44
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Answered SAE form for hypertension
attack was fulfilled and
sent to sponsor on
27Nov2020 and AE CRF
page was completed.
Dec-01-2020
15:47:18
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020470878
Hypertension attack(onset
date:24Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Dec-01-2020
15:46:43
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020470878
Chest pain(onset
date:24Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Nov-06-2020
16:31:18
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12131049Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Nov-06-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1958Enrollment Entry
3. Sex:
Date Location User Value Reason
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821142
Page 83 of 156
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-06-2020 16:32:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-06-2020 16:32:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-06-2020 16:32:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821143
Page 84 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 16:32:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821144
Page 85 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-06-2020 16:33:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020 16:33:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020 16:33:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821145
Page 86 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-06-2020 16:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
2008
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-06-2020 16:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020 16:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-06-2020 16:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-06-2020 16:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821146
Page 87 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-06-2020 16:42:24
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Type-2 Diabete
s Mellitus
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Nov-06-2020 16:42:24
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020 16:42:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Type-2 Diabetes MellitusInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-06-2020 16:42:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-06-2020 16:42:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-09-2020 20:55:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Line/MH Num 3Transcription Error
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821147
Page 88 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ber:
Medical Histor
y Term:Hyperlipide
mia
Start Date: UNK/UNK
/2019
Ongoing: YES
Nov-06-2020 16:43:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Hyperlipem
ia
Start Date: UNK/UNK
/2019
Ongoing: YESInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821148
Page 89 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Nov-06-2020 16:43:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-10-2020 12:13:35
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 20:55:58
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-09-2020 20:55:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HyperlipidemiaTranscription Error
Nov-09-2020 18:16:10
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened clinical query: can
you please clarify
the term
hyperlipemia? Is
hyperlipidemia?
Thanks
Nov-06-2020 16:43:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HyperlipemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-06-2020 16:43:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-06-2020 16:43:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821149
Page 90 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-06-2020 16:34:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821150
Page 91 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
92.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
176.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.7Initial Entry
7.a
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821151
Page 92 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.1
Temperature Uni
t:C
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-06-2020 16:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821152
Page 93 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-06-2020 16:35:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-06-2020 16:35:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
274103Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821153
Page 94 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-08-2020 18:35:18
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-08-2020 18:35:18
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-08-2020 18:35:47
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-08-2020 18:35:18
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-08-2020 18:35:18
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-08-2020 18:35:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZCV8Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821154
Page 95 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-08-2020 18:35:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZCV8Initial Entry
5.b
Date Location User Value Reason
Nov-08-2020 18:36:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZCV9Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-08-2020 18:36:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZCV9Initial Entry
5.c
Date Location User Value Reason
Nov-08-2020 18:36:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHCKMInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-08-2020 18:36:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHCKMInitial Entry
5.d
Date Location User Value Reason
Nov-08-2020 18:36:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHCKNInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821155
Page 96 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Nov-08-2020 18:36:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHCKNInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821156
Page 97 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-08-2020 18:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-08-2020 18:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-08-2020 18:55:33
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-08-2020 18:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-08-2020 18:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-08-2020 18:55:33
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZCV7Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821157
Page 98 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-08-2020 18:55:33
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZCV7Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821158
Page 99 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/6/2020 11:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821159
Page 100 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-06-2020 16:35:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821160
Page 101 of 156
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-06-2020 16:36:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821161
Page 102 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-27-2020 12:11:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/27/2020Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821162
Page 103 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821163
Page 104 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821164
Page 105 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821165
Page 106 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821166
Page 107 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821167
Page 108 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821168
Page 109 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::RE
DN
ES
S
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.a Injection Site Reaction:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821169
Page 110 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-27-2020 12:13:49 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821170
Page 111 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul Injection Site React
ion::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on
the last day the Sub
ject Diary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-27-2020 12:13:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821171
Page 112 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/27/2020Initial Entry
2.a
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.1
Temperature Uni
t:C
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821172
Page 113 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-27-2020 12:14:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821173
Page 114 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-27-2020 12:14:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-27-2020 12:14:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-27-2020 22:19:21
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-27-2020 12:14:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-27-2020 12:14:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/27/2020Initial Entry
5.a
Date Location User Value Reason
Nov-27-2020 22:19:21
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZCXYInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821174
Page 115 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-27-2020 22:19:21
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZCXYInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821175
Page 116 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/27/2020 11:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821176
Page 117 of 156
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-27-2020 12:15:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821177
Page 118 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-26-2020 15:59:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/25/2020Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821178
Page 119 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821179
Page 120 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821180
Page 121 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821181
Page 122 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821182
Page 123 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821183
Page 124 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821184
Page 125 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::RE
DN
ES
S
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.a Injection Site Reaction:
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821185
Page 126 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-26-2020 16:00:14 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821186
Page 127 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul Injection Site React
ion::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on
the last day the Sub
ject Diary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-26-2020 16:00:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821187
Page 128 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-26-2020 16:00:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-26-2020 16:00:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-26-2020 16:00:59
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-26-2020 16:00:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-26-2020 16:00:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/25/2020Initial Entry
5.a
Date Location User Value Reason
Dec-26-2020 16:00:59
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BN8M88Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821188
Page 129 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-26-2020 16:00:59
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BN8M88Initial Entry
5.b
Date Location User Value Reason
Dec-26-2020 16:01:09
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BN8M89Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-26-2020 16:01:09
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BN8M89Initial Entry
5.c
Date Location User Value Reason
Dec-26-2020 16:01:29
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHCSKInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-26-2020 16:01:29
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHCSKInitial Entry
5.d
Date Location User Value Reason
Dec-26-2020 16:01:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHCSLInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821189
Page 130 of 156
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Dec-26-2020 16:01:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHCSLInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821190
Page 131 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821191
Page 132 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Dec-17-2020 11:52:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Deleted Transcription
Error
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821192
Page 133 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Jan-17-2021
13:53:59
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
4: Clo
sedResponse satisfies
query
Jan-15-2021
12:22:49
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
4: Ans
weredTranscription Error
Jan-15-2021
12:22:49
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Hyper
tensiv
e crisi
sTranscription Error
Jan-15-2021
02:56:12
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery
3: Clo
sedResponse satisfies
query
Jan-13-2021
14:45:26
(UTC+03:00)ACV0PFEINFP6000 Query
4: Ope
nedSAE RECON:
AER#2020470878,the
term was reported as
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821193
Page 134 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul 'hypertensive crisis' in
Safety database while
recorded as
'Hypertensive
Urgency' in AE CRF.
Please confirm
correct term.If safety
update is required,
please submit a
follow-up form.
Jan-11-2021
11:14:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredTranscription Error
Jan-11-2021
11:14:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Hyper
tensiv
e Urge
ncyTranscription Error
Dec-23-2020
22:46:38
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery
2: Clo
sedResponse satisfies
query
Dec-23-2020
21:39:44
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
2: Ans
weredSystolic /diastolic BP
is 200/100 mm and
SAE FU report was
updated.
Dec-21-2020
21:13:56
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery
3: Ope
nedClinical_ Per case
narrative the subject
experienced
"Hypertension
attack". Kindly clarify
is this is was a case of
hypertensive urgency
vs emergency and
update AE
accordingly. Thank
you.
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821194
Page 135 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-17-2020
22:15:32
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery
2: Ope
nedGPDClin: Please try
to obtain BP
measures during the
event to support the
diagnosis term of
hypertensive crisis
and include it in SAE
FU report.
Dec-17-2020
18:46:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Hyper
tensiv
e Crisi
sTranscription Error
Dec-02-2020
11:33:30
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Dec-02-2020
10:34:59
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Dec-02-2020
10:34:59
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Chest
PainTranscription Error
Dec-01-2020
19:47:14
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Ope
nedClarify 2020470878
as follows...Please
update the verbatim
term to specify the
symptom, diagnosis
or procedure being
reported. Thank you.
Dec-01-2020
16:13:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
20204
70878Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821195
Page 136 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/24/2020 21:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/25/2020 22:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-28-2020 23:40:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Dec-28-2020 11:29:35
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Dec-28-2020 11:29:35
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
3Transcription Error
Dec-23-2020 22:47:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Per your
answer, please
change the grade to
"3".
Dec-23-2020 21:36:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Answered Since
systolic/diastolic
BP is =200/10
mmHg for this
subject, severity of
hypertensive crisis
evaluated as grade
3.
Dec-17-2020 21:58:39 ACV0PFEINFP6000 Quan Jason Query 1: Opened GPDClin: Please
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821196
Page 137 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul Gong clarify the severity
of this hypertensive
crisis case.
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-02-2020 10:49:36
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-02-2020 10:34:59
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Chest
Pain: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
2020470878:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NOInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821197
Page 138 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-12-2021 04:10:40
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 2: Closed Response satisfies
query
Jan-11-2021 11:15:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821198
Page 139 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-11-2021 11:15:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
Hypertensive urgencyTranscription Error
Jan-05-2021 18:58:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 2: Reissued:Opened GPDClin: Chest
pain was likely a
symptom of
hypertensive crisis,
not its cause. Please
enter the suspected
cause of
hypertensive crisis
here.
Dec-22-2020 12:56:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Answered This subject was
admitted to hospital
on 24Nov2020 with
chest pain
complaints
therefore chest pain
was evaluated as
one of
signs/symptoms of
hypertensive crisis.
Dec-17-2020 22:03:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 2: Opened GPDClin: It is
unclear why chest
pain was the
suspected cause of
hypertensive crisis.
Please clarify.
Dec-09-2020 01:36:29
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Dec-08-2020 17:30:05 ACV0PFEINFP6000 auto query Query 1: Answered Transcription Error
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821199
Page 140 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul (autoquery)
Dec-08-2020 17:30:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
Chest PainTranscription Error
Dec-03-2020 06:39:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Per SAE
report, the event
was not attributed
to study drug or
concomitant
medications. Please
clarify if this entry
is correct. If yes,
which conmed was
considered causally
related to this
SAE?
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
CONCOMITANT DRUG
TREATMENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821200
Page 141 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-01-2020 16:13:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-02-2020 10:49:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2020470878Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821201
Page 142 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-21-2020
21:10:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle Castillo Query
3: Clo
sedThe query will
be placed on
different form.
Dec-17-2020
22:17:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason Gong Query
1: Clo
sedResponse
satisfies query
Dec-17-2020
11:52:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
3: An
swere
dTranscription
Error
Dec-17-2020
11:52:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Dec-15-2020
04:28:13
(UTC+03:00)ACV0PFEINFP6000 Giselle Castillo Query
3: Op
enedPer case
narrative the
subject
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821202
Page 143 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Istanbul experienced
"Hypertension
attack".
Kindly clarify
is this is was a
case of
hypertensive
urgency vs
emergency
and update AE
accordingly.
Thank you.
Dec-09-2020
08:25:33
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
2: Clo
sedResponse
satisfies query
Dec-09-2020
01:52:53
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason Gong Query
1: Rei
ssued:
Open
edGPDClin: Did
you mean
"Worsening
hypertension"?
If yes, please
modify the
term. In
addition,
please also
submit an
update SAE
report for the
term change.
Dec-08-2020
22:22:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dChanged
Information
Dec-08-2020
22:22:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged
Information
Dec-08-2020
22:22:45ACV0PFEINFP6000 Data
EntryChanged
Information
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821203
Page 144 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC+03:00)
Istanbul:
Worse
ning
Hyper
tensio
n Atta
ck
Dec-03-2020
13:33:21
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Op
enedThe AE
Hypertension
Attack was
reported but is
also listed in
Medical
History. Please
clarify if this
is a worsening
of the baseline
condition, and
if so, please
consider
adding
"worsening" to
the AE term.
AE as baseline
conditions
should only be
reported as
AEs if they
worsen.
Dec-03-2020
06:33:51
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason Gong Query
1: Op
enedGPDClin:
Please clarify
the following
issues in the
answer: 1)
Meaning of
the term and
the discharge
diagnosis. Per
SAE report,
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821204
Page 145 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
the event was
unlikely to be
hypertensive
crisis or heart
attack. 2)
blood pressure
measures and
ECG result.
Dec-02-2020
10:42:42
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Hyper
tensio
n Atta
ckInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/24/2020 21:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/25/2020 22:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821205
Page 146 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-02-2020 10:50:01
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Hypertension
Attack: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821206
Page 147 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-09-2020 01:54:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Dec-08-2020 17:48:42
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Dec-08-2020 17:48:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
HypertensionTranscription
Error
Dec-03-2020 06:37:59
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Per
SAE report, the
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821207
Page 148 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
event was not
attributed to study
drug or
concomitant
medications.
Please clarify if
this entry is
correct.
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
CONCOMITANT DRUG
TREATMENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821208
Page 149 of 156
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-02-2020 10:42:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-02-2020 10:50:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2020470878Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821209
Page 150 of 156
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-26-2020 16:02:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-26-2020 16:02:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-26-2020 16:02:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821210
Page 151 of 156
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021 16:50:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/31/2020Transcription Error
Jan-07-2021 16:44:15
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 16:35:43
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check
whether other
assessments are
performed at this
visit.
Jan-07-2021 16:31:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-07-2021 16:44:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Transcription Error
Jan-07-2021 16:35:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821211
Page 152 of 156
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-21-2021 17:57:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Close per query
response
Jan-20-2021 17:01:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Answered Data is recorrected.
Jan-20-2021 16:47:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-20-2021 15:26:24
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-20-2021 15:26:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible and NOT confirm
ed to have received only
placebo at Vaccination 1/
2Transcription Error
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821212
Page 153 of 156
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-07-2021 16:51:19
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Participant is NOT willing to
return for Vaccination 3 OR
otherwise not eligibleInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821213
Page 154 of 156
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-21-2021 13:36:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/31/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-21-2021 13:36:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821214
Page 155 of 156
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-26-2020 16:02:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-06-2020 16:35:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-06-2020 16:33:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-26-2020 16:02:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/25/2020Initial Entry
Nov-06-2020 16:35:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
Nov-06-2020 16:33:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821215
Page 156 of 156
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1213 Site Name: (1213) Istanbul University Cerrahpaşa Medical Faculty
Subject No: 12131049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-02-2020 15:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30cd\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0821216