125742 S1 M5 CRF c4591001 1210 12101026

Document text

Page 1 of 452
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845700
Page 2 of 452
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
Oct/30/2020
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845701
Page 3 of 452
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12101026]
2.Birth Date: 1973
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:
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845702
Page 4 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845703
Page 5 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845704
Page 6 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845705
Page 7 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845706
Page 8 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845707
Page 9 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/30/2020
2.Weight: [86.0]
3.Unit: kg
4.Height: [183.0]
5.Unit: cm
6.Body Mass Index: [25.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845708
Page 10 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/30/2020
2.Randomization Number: [114315]
3.Randomization Group: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845709
Page 11 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
Oct/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCXND]
5.bSample ID [BRCXNC]
5.cSample ID [BSHB2S]
5.dSample ID [BSHB2T]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845710
Page 12 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
Oct/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCXNF]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845711
Page 13 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: Oct/30/2020 10:50
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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845712
Page 14 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845713
Page 15 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845714
Page 16 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845715
Page 17 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845716
Page 18 of 452
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845717
Page 19 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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/11/2020
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 [BRCXVM]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845718
Page 20 of 452
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: Dec/11/2020 10:20
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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845719
Page 21 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021 Comments
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845720
Page 22 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845721
Page 23 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO Comments
3.Injection Site Location: DELTOID MUSCLE Comments
4.Injection Site Body Side: LEFT Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845722
Page 24 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Jan/13/2021Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNLLLB]
5.bSample ID [BNLLLC]
5.cSample ID [BR0YZL]
5.dSample ID [BR0YZM]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845723
Page 25 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845724
Page 26 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/10/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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? YES
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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845725
Page 27 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845726
Page 28 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/7/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 2.Nov/9/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845727
Page 29 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: Nov/7/2020
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: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Bioeksen Bio-Speedy Direct RT-qPCR SARS-CoV-2]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845728
Page 30 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: Nov/9/2020
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: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Bioeksen Bio-Speedy Direct RT-qPCR SARS-CoV-2]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845729
Page 31 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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? YES
Date of Collection:
Nov/10/2020
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 [BRCXT1]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845730
Page 32 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[collected self swab]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCXT1 ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845731
Page 33 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: YES
Number of Visits or Contacts:
[2]
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: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845732
Page 34 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
 1. DELETED HOSPITALIZATION STAT
US HOSPITAL   Nov/16/2020  NO
Discharge Dat
e:
Nov/23/2020
 Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845733
Page 35 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/16/2020
4.Ongoing? NO
Discharge Date:
Nov/23/2020
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845734
Page 36 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845735
Page 37 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845736
Page 38 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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?NO
3.Toxicity Grade: 2
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845737
Page 39 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845738
Page 40 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845739
Page 41 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845740
Page 42 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845741
Page 43 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845742
Page 44 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845743
Page 45 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845744
Page 46 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845745
Page 47 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845746
Page 48 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845747
Page 49 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845748
Page 50 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845749
Page 51 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845750
Page 52 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845751
Page 53 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845752
Page 54 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
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(b) (4)
FDA-CBER-2021-5683-0845753
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***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Nov/17/2020 Record Identifier: Oxygen Saturation
1  92.0 Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845754
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [92.0]
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(b) (4)
FDA-CBER-2021-5683-0845755
Page 57 of 452
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845756
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845757
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***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845758
Page 60 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
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(b) (4)
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***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of As
sessmentLocation of
AssessmentImaging
MethodOverall AssessmentForm Instan
ce
 1.Nov/16/20
20 CHEST  CT SCA
N ABNORMAL
If abnormal, specify findings:
In both lungs, ground glass appearance and areas of increas
ed density consistent with consolidation are observed.
 Repeating
Pages
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(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/16/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[In both lungs, ground glass appearance and areas of increased density
consistent with consolidation are observed.]
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(b) (4)
FDA-CBER-2021-5683-0845761
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***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
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(b) (4)
FDA-CBER-2021-5683-0845762
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***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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/11/2020
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 [BRCXVL]
5.bSample ID [BRCXVK]
5.cSample ID [BSHB5L]
5.dSample ID [BSHB5K]
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(b) (4)
FDA-CBER-2021-5683-0845763
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***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
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(b) (4)
FDA-CBER-2021-5683-0845764
Page 66 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845765
Page 67 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Acute upper respiratory tra
ct infections Nov/16/2020 UN
K:UNK NO
End Date Time:
Dec/7/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  Acute upper respiratory tra
ct infections Nov/7/2020 UN
K:UNK NO
End Date Time:
Nov/16/2020 UNK:U
NK
 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0845766
Page 68 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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)[Acute upper respiratory tract infections]
4.Start Date Time: Nov/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/7/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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(b) (4)
FDA-CBER-2021-5683-0845767
Page 69 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Suspected COVID19]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020470537]
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(b) (4)
FDA-CBER-2021-5683-0845768
Page 70 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute upper respiratory tract infections]
4.Start Date Time: Nov/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/16/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[suspected covid 19]
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(b) (4)
FDA-CBER-2021-5683-0845769
Page 71 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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?NO
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[ ]
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(b) (4)
FDA-CBER-2021-5683-0845770
Page 72 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0845771
Page 73 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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[ ]
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(b) (4)
FDA-CBER-2021-5683-0845772
Page 74 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845773
Page 75 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
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(b) (4)
FDA-CBER-2021-5683-0845774
Page 76 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845775
Page 77 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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?
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(b) (4)
FDA-CBER-2021-5683-0845776
Page 78 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845777
Page 79 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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?
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845778
Page 80 of 452
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845779
Page 81 of 452
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845780
Page 82 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845781
Page 83 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845782
Page 84 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845783
Page 85 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845784
Page 86 of 452
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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?
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845785
Page 87 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845786
Page 88 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845787
Page 89 of 452
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Jan/13/2021 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845788
Page 90 of 452
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845789
Page 91 of 452
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845790
Page 92 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845791
Page 93 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845792
Page 94 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845793
Page 95 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
[ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845794
Page 96 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845795
Page 97 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
Jan/20/2021
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845796
Page 98 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845797
Page 99 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
:Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845798
Page 100 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
Jan/20/2021
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 [BR0Z0F]
5.bSample ID [BR0Z0G]
5.cSample ID [BNLLLP]
5.dSample ID [BNLLLR]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845799
Page 101 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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:
Jan/20/2021
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 [BR0Z0D]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845800
Page 102 of 452
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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: Jan/20/2021 09:50
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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845801
Page 103 of 452
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845802
Page 104 of 452
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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/12/2021
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 [BR0Z1B]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845803
Page 105 of 452
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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/12/2021 11:00
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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845804
Page 106 of 452
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845805
Page 107 of 452
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/12/2021
3.Comments: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845806
Page 108 of 452
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845807
Page 109 of 452
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845808
Page 110 of 452
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845809
Page 111 of 452
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845810
Page 112 of 452
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/12/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845811
Page 113 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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 Jan/13/2021
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845812
Page 114 of 452
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845813
Page 115 of 452
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845814
Page 116 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 18:38:28 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845815
Page 117 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 18:40:16 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845816
Page 118 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 09:59:48 (UTC+03:00) Istanbul Could you please delete 18Dec2020 date on this
form. It was entered by mistake.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845817
Page 119 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 10:01:25 (UTC+03:00) Istanbul Could you please delete 18Dec2020 date on this
form. It was entered by mistake.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845818
Page 120 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-13-2021 09:53:25 (UTC+03:00) Istanbul
FormDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
FormDec-18-2020 12:30:05 (UTC+03:00) Istanbul not applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845819
Page 121 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-13-2021 09:53:25 (UTC+03:00) Istanbul
1Dec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845820
Page 122 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.aDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845821
Page 123 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.bJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.bDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845822
Page 124 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.cJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.cDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845823
Page 125 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.dJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.dDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845824
Page 126 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.eJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.eDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845825
Page 127 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 fJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2 fDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845826
Page 128 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.gJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2.gDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845827
Page 129 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 hJan-13-2021 09:53:25 (UTC+03:00) Istanbul
2 hDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845828
Page 130 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-13-2021 09:53:25 (UTC+03:00) Istanbul
3Dec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845829
Page 131 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-13-2021 09:53:25 (UTC+03:00) Istanbul
4Dec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845830
Page 132 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-13-2021 09:53:25 (UTC+03:00) Istanbul
5.aDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845831
Page 133 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-13-2021 09:53:25 (UTC+03:00) Istanbul
5.bDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845832
Page 134 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-13-2021 09:53:25 (UTC+03:00) Istanbul
5.cDec-22-2020 11:48:27 (UTC+03:00) Istanbul not applicable
Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845833
Page 135 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-13-2021 09:54:23 (UTC+03:00) Istanbul
FormDec-23-2020 11:15:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845834
Page 136 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-13-2021 09:54:23 (UTC+03:00) Istanbul
1Dec-23-2020 11:15:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845835
Page 137 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-13-2021 09:54:23 (UTC+03:00) Istanbul
2Dec-23-2020 11:15:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845836
Page 138 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-13-2021 09:54:23 (UTC+03:00) Istanbul
3Dec-23-2020 11:15:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845837
Page 139 of 452
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-13-2021 09:54:23 (UTC+03:00) Istanbul
4Dec-23-2020 11:15:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845838
Page 140 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845839
Page 141 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845840
Page 142 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845841
Page 143 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845842
Page 144 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845843
Page 145 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845844
Page 146 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845845
Page 147 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:19:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845846
Page 148 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:19:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845847
Page 149 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:19:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845848
Page 150 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:19:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845849
Page 151 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-27-2020 18:19:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845850
Page 152 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845851
Page 153 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845852
Page 154 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845853
Page 155 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845854
Page 156 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845855
Page 157 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845856
Page 158 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845857
Page 159 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845858
Page 160 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845859
Page 161 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845860
Page 162 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845861
Page 163 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845862
Page 164 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845863
Page 165 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845864
Page 166 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845865
Page 167 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845866
Page 168 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845867
Page 169 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845868
Page 170 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845869
Page 171 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845870
Page 172 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845871
Page 173 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845872
Page 174 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845873
Page 175 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845874
Page 176 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845875
Page 177 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845876
Page 178 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845877
Page 179 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845878
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845879
Page 181 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845880
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845881
Page 183 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845882
Page 184 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:36:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845883
Page 185 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845884
Page 186 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845885
Page 187 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845886
Page 188 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845887
Page 189 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845888
Page 190 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845889
Page 191 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845890
Page 192 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845891
Page 193 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845892
Page 194 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845893
Page 195 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845894
Page 196 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845895
Page 197 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845896
Page 198 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845897
Page 199 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845898
Page 200 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845899
Page 201 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845900
Page 202 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845901
Page 203 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845902
Page 204 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845903
Page 205 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845904
Page 206 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845905
Page 207 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845906
Page 208 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845907
Page 209 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845908
Page 210 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845909
Page 211 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845910
Page 212 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845911
Page 213 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845912
Page 214 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845913
Page 215 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845914
Page 216 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845915
Page 217 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845916
Page 218 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845917
Page 219 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845918
Page 220 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845919
Page 221 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845920
Page 222 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845921
Page 223 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845922
Page 224 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845923
Page 225 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845924
Page 226 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845925
Page 227 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845926
Page 228 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845927
Page 229 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-27-2020 18:37:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845928
Page 230 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845929
Page 231 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845930
Page 232 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aNov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845931
Page 233 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aNov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845932
Page 234 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aNov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845933
Page 235 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aNov-27-2020 18:38:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845934
Page 236 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:38:37 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845935
Page 237 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:38:37 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845936
Page 238 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:38:37 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845937
Page 239 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:38:37 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845938
Page 240 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845939
Page 241 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845940
Page 242 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845941
Page 243 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845942
Page 244 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845943
Page 245 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845944
Page 246 of 452
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-27-2020 18:39:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845945
Page 247 of 452
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-13-2021 10:28:00 (UTC+03:00) Istanbul
FormDec-01-2020 11:52:51 (UTC+03:00) Istanbul Not Done
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845946
Page 248 of 452
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-13-2021 10:28:00 (UTC+03:00) Istanbul
1Dec-01-2020 11:52:51 (UTC+03:00) Istanbul Not Done
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845947
Page 249 of 452
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-13-2021 10:28:00 (UTC+03:00) Istanbul
2Dec-01-2020 11:52:51 (UTC+03:00) Istanbul Not Done
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845948
Page 250 of 452
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-13-2021 10:28:00 (UTC+03:00) Istanbul
3Dec-01-2020 11:52:51 (UTC+03:00) Istanbul Not Done
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845949
Page 251 of 452
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-13-2021 10:28:00 (UTC+03:00) Istanbul
4Dec-01-2020 11:52:51 (UTC+03:00) Istanbul Not Done
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845950
Page 252 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-19-2021 15:36:38 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845951
Page 253 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-19-2021 15:36:38 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845952
Page 254 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-19-2021 15:36:52 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845953
Page 255 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-19-2021 15:36:52 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845954
Page 256 of 452
***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: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 13:05:31 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845955
Page 257 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-12-2021 13:11:39 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Feb-16-2021 15:08:17 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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-12-2021 16:23:37 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Feb-10-2021 10:52:47 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845956
Page 258 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Feb-09-2021 09:56:02 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-21-2021 11:49:58 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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 Jan-19-2021 15:21:37 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-19-2021 15:05:18 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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 Jan-13-2021 09:50:41 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-05-2021 16:53:22 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845957
Page 259 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-23-2020 11:15:05 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-22-2020 13:55:45 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-18-2020 12:23:29 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-14-2020 17:35:24 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845958
Page 260 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Dec-14-2020 10:04:40 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-07-2020 16:16:23 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-07-2020 11:27:17 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-02-2020 13:51:29 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-01-2020 15:17:27 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-01-2020 14:23:25 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845959
Page 261 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-27-2020 18:18:56 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-27-2020 16:14:14 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-26-2020 12:23:47 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-25-2020 13:48:42 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, 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.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845960
Page 262 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Nov-23-2020 16:50:52 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-17-2020 16:25:05 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 16:24:29 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-17-2020 16:24:28 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 15:46:36 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-10-2020 17:38:26 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845961
Page 263 of 452
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 14:16:02 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-10-2020 14:15:53 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, AliMert, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 09:31:05 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-03-2020 17:14:33 (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.
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845962
Page 264 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
Oct-30-2020 11:48:00
(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
Oct-30-2020 11:48:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845963
Page 265 of 452
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-30-2020 11:48:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/30/2020Initial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845964
Page 266 of 452
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-30-2020 11:47:45
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12101026Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 11:47:41
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020 11:48:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-30-2020 11:48:24
(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
Oct-30-2020 11:48:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845965
Page 267 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 18:38:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845966
Page 268 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
Oct-30-2020 18:38:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 18:38:46
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 18:38:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845967
Page 269 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 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
Oct-30-2020 18:40:28
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845968
Page 270 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020 18:55:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
86.0Transcription Error
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
71.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020 18:55:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
183.0Transcription Error
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
176.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0845969
Page 271 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020 18:55:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.7Transcription Error
Oct-30-2020 18:55:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.8Transcription Error
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.9Initial Entry
7.a
Date Location User Value Reason
Oct-30-2020 18:56:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADTranscription Error
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020 18:56:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.3Transcription Error
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0845970
Page 272 of 452
***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, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020 18:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845971
Page 273 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-30-2020 18:41:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020 18:57:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
114315Transcription Error
Oct-30-2020 18:41:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
114309Initial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845972
Page 274 of 452
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 18:41:48
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 18:41:48
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 18:42:39
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 18:41:48
(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.
Oct-30-2020 18:41:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 18:58:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXNDTranscription Error
Oct-30-2020 18:42:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXN8Initial Entry
090177e196ae2fe1\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845973
Page 275 of 452
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr
…[truncated]