Document text
Page 1 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845345
Page 2 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/3/2020
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845346
Page 3 of 355
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12091014]
2.Birth Date: 1960
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:
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845347
Page 4 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845348
Page 5 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845349
Page 6 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845350
Page 7 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845351
Page 8 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845352
Page 9 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/3/2020
2.Weight: [90.0]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [29.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845353
Page 10 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/3/2020
2.Randomization Number: [272972]
3.Randomization Group: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845354
Page 11 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/3/2020
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 [BPZBMH]
5.bSample ID [BPZBMJ]
5.cSample ID [BRZDN7]
5.dSample ID [BRZDN8]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845355
Page 12 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/3/2020
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 [BPZBMC]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845356
Page 13 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/3/2020 10:07
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845357
Page 14 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845358
Page 15 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845359
Page 16 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845360
Page 17 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845361
Page 18 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845362
Page 19 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/24/2020
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 [BPZBNT]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845363
Page 20 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/24/2020 09:32
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845364
Page 21 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845365
Page 22 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845366
Page 23 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845367
Page 24 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/31/2020
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 [BPZBR8]
5.bSample ID [BPZBR9]
5.cSample ID [BRZDR5]
5.dSample ID [BRZDR6]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845368
Page 25 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845369
Page 26 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/20/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845370
Page 27 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.Symptoms - Other Text: [ ]
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(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/18/202
0 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845372
Page 29 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/18/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Bioeksen Bio Speedy Direct RT qPCR SARS CoV 2]
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(b) (4)
FDA-CBER-2021-5683-0845373
Page 30 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[The subject didn't want to use self swab kit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0845374
Page 31 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
Dec/31/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[The subject was not avaliable yet to visit the site for nasal swab. They've been
discharged from hospital on 25 dec (their pcr result is negative)]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBR7]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845375
Page 32 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[3]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Done
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19
illness?
NO
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845376
Page 33 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Dec/18/2020 NO
Discharge Date:
Dec/25/2020
Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845377
Page 34 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/18/2020
4.Ongoing? NO
Discharge Date:
Dec/25/2020
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845378
Page 35 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845379
Page 36 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845380
Page 37 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 pneumonia]
Date of Diagnosis:
Dec/18/2020
3.Toxicity Grade: 1
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(b) (4)
FDA-CBER-2021-5683-0845381
Page 38 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845382
Page 39 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845383
Page 40 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.CLINICAL
CHEMISTR
Y American Hospital (Amerikan Hastanesi) Tesvi
kiye, Guzelbahce St. No:20, 34365 Sisli/Istanb
ul/Turkey Dec/25/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 Not
Done
11,6
30 Not
Done
93
28 Not
Done
74
35 Not
Done
21 Not
Done
47 Not
Done
48 Not
Done
0,8 Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845384
Page 41 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [American Hospital (Amerikan Hastanesi) Tesvikiye, Guzelbahce St.
No:20, 34365 Sisli/Istanbul/Turkey]Comments
3.Collection Date: Dec/25/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [11,6] Comments
Not Done: Comments
LNMT Low
[0]
High
[5]
Unit
mg/LComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [93] Comments
Not Done: Comments
LNMT Low
[0]
High
[41]
Unit
U/LComments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845385
Page 42 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [74] Comments
Not Done: Comments
LNMT Low
[0]
High
[40]
Unit
U/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5 fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845386
Page 43 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [0,8] Comments
Not Done: Comments
LNMT Low
[0,8]
High
[1,3]
Unit
mg/dLComments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845387
Page 44 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category f
or Lab Te
stVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY American Hospital (Amerikan Hastanesi) Tes
vikiye, Guzelbahce St. No:20, 34365 Sisli/Ist
anbul/Turkey Dec/18/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglob
in_PX1 15,
4
2 Hematocri
t_PX2 45
3 Erythrocy
tes_PX3 5,1
5
5 Platelets_
PX5 [ ]
7 Leukocyte
s_PX7 7,6
8
608 Neutrophi
ls_PX608 4,3
609 Eosinophi
ls_PX609 0
612 Monocyte
s_PX612 1,1
610 Basophils
_PX610 0,0
611 Lymphoc
ytes_PX6
11 2,2 Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845388
Page 45 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [American Hospital (Amerikan Hastanesi) Tesvikiye, Guzelbahce St. No:20, 34365
Sisli/Istanbul/Turkey]
3.Collection Date: Dec/18/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15,4]
Not Done:
LNMT Low
[13,1]
High
[17,2]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [45]
Not Done:
LNMT Low
[38]
High
[51]
Unit
%
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845389
Page 46 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5,15]
Not Done:
LNMT Low
[4,5]
High
[6,1]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [7,68]
Not Done:
LNMT Low
[4,1]
High
[11,1]
Unit
/uL
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845390
Page 47 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4,3]
Not Done:
LNMT Low
[1,8]
High
[7,5]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[0,0]
High
[0,5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1,1]
Not Done:
LNMT Low
[0,0]
High
[1,0]
Unit
/uL
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845391
Page 48 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0,0]
Not Done:
LNMT Low
[0,0]
High
[0,1]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2,2]
Not Done:
LNMT Low
[1,2]
High
[5,8]
Unit
/uL
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845392
Page 49 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845393
Page 50 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845394
Page 51 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845395
Page 52 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845396
Page 53 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845397
Page 54 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845398
Page 55 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
2.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
3.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845399
Page 56 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845400
Page 57 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845401
Page 58 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845402
Page 59 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assess
mentLocation of Assess
mentImaging Met
hodOverall Assessment Form Instance
1.Dec/18/2020 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
there is icy glass appearance of the upper and down l
obe of left lung
Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845403
Page 60 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/18/2020 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: CT SCAN Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[there is icy glass appearance of the upper and down lobe of left lung]Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845404
Page 61 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/02/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845405
Page 62 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/02/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
Feb/2/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBS5]
5.bSample ID [BPZBS6]
5.cSample ID [BRZDRV]
5.dSample ID [BRZDRW]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845406
Page 63 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845407
Page 64 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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 [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845408
Page 65 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 COVID-19 Illne
ss Dec/18/2020 UNK:U
NK NO
End Date Time:
Dec/23/2020 UNK:UNK
Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845409
Page 66 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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)[COVID-19 Illness]
4.Start Date Time: Dec/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/23/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Covid-19 pandemic]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845410
Page 67 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES Comments
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[2020506841]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845411
Page 68 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ongo
ingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845412
Page 69 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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[ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845413
Page 70 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medicatio
nStart Dat
eForm Instanc
e
1.1 VACCINATIONS NO SKY Cellflu Quadri
valent Dec/16/20
20 Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845414
Page 71 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[SKY Cellflu Quadrivalent]
5.Date: Dec/16/2020
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845415
Page 72 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845416
Page 73 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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?
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845417
Page 74 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845418
Page 75 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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?
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845419
Page 76 of 355
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845420
Page 77 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845421
Page 78 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845422
Page 79 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845423
Page 80 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845424
Page 81 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845425
Page 82 of 355
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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?
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845426
Page 83 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845427
Page 84 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845428
Page 85 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/31/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845429
Page 86 of 355
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845430
Page 87 of 355
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845431
Page 88 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845432
Page 89 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845433
Page 90 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845434
Page 91 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845435
Page 92 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845436
Page 93 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/26/2021
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845437
Page 94 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845438
Page 95 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845439
Page 96 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
Feb/26/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBSW]
5.bSample ID [BPZBSX]
5.cSample ID [BRZDRZ]
5.dSample ID [BRZDS0]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845440
Page 97 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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:
Feb/26/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBSV]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845441
Page 98 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 10:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845442
Page 99 of 355
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845443
Page 100 of 355
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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 [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845444
Page 101 of 355
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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?
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845445
Page 102 of 355
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845446
Page 103 of 355
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845447
Page 104 of 355
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845448
Page 105 of 355
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845449
Page 106 of 355
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845450
Page 107 of 355
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845451
Page 108 of 355
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845452
Page 109 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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/31/2020
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845453
Page 110 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845454
Page 111 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
Approved Mar-11-2021 13:54:14 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845455
Page 112 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-03-2020 14:25:25 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845456
Page 113 of 355
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-03-2020 14:31:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845457
Page 114 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-07-2021 16:08:03 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845458
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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ItemDate User Comment
FormDec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845459
Page 116 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845460
Page 117 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845461
Page 118 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845462
Page 119 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845463
Page 120 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845464
Page 121 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-29-2020 20:11:48 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845465
Page 122 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 20:12:42 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845466
Page 123 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 20:12:42 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845467
Page 124 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-29-2020 20:12:42 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845468
Page 125 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-29-2020 20:12:42 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845469
Page 126 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-29-2020 20:12:42 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845470
Page 127 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 14:35:40 (UTC+03:00) Istanbul
FormDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845471
Page 128 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 14:35:40 (UTC+03:00) Istanbul
1Dec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845472
Page 129 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 14:35:40 (UTC+03:00) Istanbul
2Dec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845473
Page 130 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 14:35:40 (UTC+03:00) Istanbul
3Dec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845474
Page 131 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 14:35:40 (UTC+03:00) Istanbul
4Dec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845475
Page 132 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.aDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845476
Page 133 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.aDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845477
Page 134 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.aDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845478
Page 135 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.aDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845479
Page 136 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.bDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845480
Page 137 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.bDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845481
Page 138 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.bDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845482
Page 139 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.bDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845483
Page 140 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.cDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845484
Page 141 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.cDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845485
Page 142 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.cDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0845486
Page 143 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.cDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845487
Page 144 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.dDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845488
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.dDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845489
Page 146 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.dDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845490
Page 147 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.dDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845491
Page 148 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.eDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845492
Page 149 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.eDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845493
Page 150 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.eDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845494
Page 151 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.eDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845495
Page 152 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5 fDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845496
Page 153 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5 fDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845497
Page 154 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5 fDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845498
Page 155 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5 fDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845499
Page 156 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.gDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845500
Page 157 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.gDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845501
Page 158 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.gDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845502
Page 159 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 14:35:40 (UTC+03:00) Istanbul
5.gDec-29-2020 20:15:29 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845503
Page 160 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845504
Page 161 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845505
Page 162 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845506
Page 163 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845507
Page 164 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845508
Page 165 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-29-2020 20:30:21 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845509
Page 166 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 20:30:41 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845510
Page 167 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 20:30:41 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845511
Page 168 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-29-2020 20:30:41 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845512
Page 169 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 20:31:02 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845513
Page 170 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 20:31:02 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845514
Page 171 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-29-2020 20:31:02 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845515
Page 172 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-29-2020 20:31:02 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845516
Page 173 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845517
Page 174 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845518
Page 175 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845519
Page 176 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845520
Page 177 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845521
Page 178 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845522
Page 179 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-01-2021 18:42:20 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845523
Page 180 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845524
Page 181 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845525
Page 182 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845526
Page 183 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845527
Page 184 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845528
Page 185 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845529
Page 186 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-07-2021 11:36:00 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845530
Page 187 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845531
Page 188 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845532
Page 189 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845533
Page 190 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845534
Page 191 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845535
Page 192 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845536
Page 193 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-07-2021 11:39:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845537
Page 194 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 14:21:37 (UTC+03:00) Istanbul
FormDec-29-2020 20:34:54 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845538
Page 195 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 14:21:37 (UTC+03:00) Istanbul
1Dec-29-2020 20:34:54 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845539
Page 196 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 14:21:37 (UTC+03:00) Istanbul
2Dec-29-2020 20:34:54 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845540
Page 197 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 14:21:37 (UTC+03:00) Istanbul
3Dec-29-2020 20:34:54 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845541
Page 198 of 355
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 14:21:37 (UTC+03:00) Istanbul
4Dec-29-2020 20:34:54 (UTC+03:00) Istanbul Not Done
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845542
Page 199 of 355
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
11Feb-04-2021 10:46:23 (UTC+03:00) Istanbul Remdesivir, Enoxaparin sodium and, Pantoprazole.
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845543
Page 200 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 14:09:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845544
Page 201 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-20-2021 14:09:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845545
Page 202 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 14:09:28 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845546
Page 203 of 355
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-20-2021 14:09:28 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0845547
Page 204 of 355
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-26-2021 09:55:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845548
Page 205 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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
Approved Mar-11-2021 13:54:14 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, , 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 Feb-02-2021 09:13:20 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 13:59:29 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845549
Page 206 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 14:20:20
(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-03-2020 14:20:20
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845550
Page 207 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-03-2020 14:20:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/3/2020Initial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845551
Page 208 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-03-2020 14:20:08
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12091014Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-03-2020 14:19:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-03-2020 14:21:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-03-2020 14:21:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-03-2020 14:21:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30cb\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-2021-5683-0845552
Page 209 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 14:25:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845553
Page 210 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 14:25:52
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020 14:25:52
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020 14:25:52
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845554
Page 211 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 14:32:18
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV P
OSITIVEInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845555
Page 212 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
90.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
175.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.4Initial Entry
7.a
Date Location User Value Reason
090177e196ae30cb\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-2021-5683-0845556
Page 213 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:
:FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-03-2020 14:35:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae30cb\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-2021-5683-0845557
Page 214 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-03-2020 14:35:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-03-2020 14:35:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
272972Initial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845558
Page 215 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 14:36:31
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 14:36:31
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 14:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 14:36:31
(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-03-2020 14:36:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020 14:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZBMHInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 14:36:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZBMHInitial Entry
090177e196ae30cb\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-2021-5683-0845559
Page 216 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b
Date Location User Value Reason
Nov-03-2020 14:37:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZBMJInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 14:37:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZBMJInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 14:37:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BRZDN7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 14:37:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BRZDN7Initial Entry
5.d
Date Location User Value Reason
Nov-03-2020 14:37:52
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BRZDN8Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-03-2020 14:37:52
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BRZDN8Initial Entry
090177e196ae30cb\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-2021-5683-0845560
Page 217 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 14:38:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 14:38:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 14:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 14:38:14
(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-03-2020 14:38:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020 14:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZBMCInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 14:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZBMCInitial Entry
090177e196ae30cb\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-2021-5683-0845561
Page 218 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020 10:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae30cb\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-2021-5683-0845562
Page 219 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION 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-03-2020 14:39:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845563
Page 220 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-03-2020 19:48:23
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845564
Page 221 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-02-2021 23:30:50
(UTC+03:00) IstanbulACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Dec-31-2020 11:38:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Answered The subject's potential
covid-19 illness visit
performed on 31 Dec
2020.
Dec-24-2020 21:59:50
(UTC+03:00) IstanbulACV0PFEINFP6000 Salim
BouguermouhQuery 1: Reissued:Opened Clin: Please this query
should remain open
until a potential
COVID-19 illness
visit is conducted and
a nasal swab could be
obtained from the
subject for the central
laboratory
Dec-24-2020 09:56:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Answered Since the subject is
not stable enough to
make pot covid illness
visit yet and their
isolation is still
ongoing, this visit will
be planned as soon as
possible.
Dec-23-2020 18:02:02
(UTC+03:00) IstanbulACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020506841 that the
subject had a
diagnosis of
COVID-19 on 21 Dec
2020 that should have
please triggered a
potential COVID
Illness Visit and a
nasal swab collected
as soon as possible
Nov-24-2020 09:37:50
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
090177e196ae30cb\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-2021-5683-0845565
Page 222 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845566
Page 223 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae30cb\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) (6)
(b) (4)
FDA-CBER-2021-5683-0845567
Page 224 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ILL
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845568
Page 225 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845569
Page 226 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT 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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae30cb\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-2021-5683-0845570
Page 227 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845571
Page 228 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020 09:38:39
(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-24-2020 09:38:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30cb\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-2021-5683-0845572
Page 229 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
2.a
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:
:FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-24-2020 09:39:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae30cb\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) (6)
(b) (4)
FDA-CBER-2021-5683-0845573
Page 230 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845574
Page 231 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 16:03:23
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 16:03:23
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 16:03:41
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-24-2020 16:03:23
(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-24-2020 16:03:23
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020 16:03:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZBNTInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020 16:03:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZBNTInitial Entry
090177e196ae30cb\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-2021-5683-0845575
Page 232 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/24/2020 09:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae30cb\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-2021-5683-0845576
Page 233 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION 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-24-2020 09:57:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845577
Page 234 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-05-2021
09:27:13
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedAs per site confirmation -
updated PD tracker
Jan-04-2021
10:20:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Ans
weredThe subject's v3 planned on
22Dec2020 but since they
were hospitalized for covid
positive on 18dec2020, they
couldn't make it to come to the
study site until 31dec2020
Jan-04-2021
09:07:39
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 2 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Dec-31-2020
09:53:56
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Dec/3
1/202
0Initial Entry
090177e196ae30cb\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)
FDA-CBER-2021-5683-0845578
Page 235 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845579
Page 236 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae30cb\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) (6)
(b) (4)
FDA-CBER-2021-5683-0845580
Page 237 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ILL
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30cb\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845581
Page 238 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845582
Page 239 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT 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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae30cb\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-2021-5683-0845583
Page 240 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae30cb\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-2021-5683-0845584
Page 241 of 355
***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: 1209 Site Name: (1209) Turkish MoH Yedikule Chest Diseases and Chest Surgery
Training and Application Center
Subject No: 12091014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-31-2020 10:02:31
(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-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-31-2020 10:02:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
Dec-31-2020 10:02:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:Initial Entry
090177e196ae30cb\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
…[truncated]