125742 S1 M5 CRF c4591001 1210 12101029

Document text

Page 1 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846152
Page 2 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846153
Page 3 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12101029]
2.Birth Date: /1983
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:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846154
Page 4 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846155
Page 5 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846156
Page 6 of 225
***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: 12101029 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: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846157
Page 7 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846158
Page 8 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846159
Page 9 of 225
***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: 12101029 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: [105.0]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [35.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846160
Page 10 of 225
***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: 12101029 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: [114945]
3.Randomization Group: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846161
Page 11 of 225
***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: 12101029 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 [BSHB2Z]
5.bSample ID [BSHB30]
5.cSample ID [BRCXNM]
5.dSample ID [BRCXNN]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846162
Page 12 of 225
***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: 12101029 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 [BSHB2Z]
5.bSample ID [BSHB30]
5.cSample ID [BRCXP3]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846163
Page 13 of 225
***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: 12101029 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 15:57
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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846164
Page 14 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846165
Page 15 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846166
Page 16 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846167
Page 17 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846168
Page 18 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846169
Page 19 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
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 [BR5DKX]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846170
Page 20 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/20/2020 10:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846171
Page 21 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846172
Page 22 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846173
Page 23 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846174
Page 24 of 225
***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: 12101029 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/18/2020
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 [BRCXWC]
5.bSample ID [BRCXWD]
5.cSample ID [BSHB6R]
5.dSample ID [BSHB6S]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846175
Page 25 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846176
Page 26 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846177
Page 27 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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 [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846178
Page 28 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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 [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846179
Page 29 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846180
Page 30 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846181
Page 31 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846182
Page 32 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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 [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846183
Page 33 of 225
***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: 12101029 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:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846184
Page 34 of 225
***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: 12101029 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 [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846185
Page 35 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  joint pain  Nov/4/2020 20:0
0 NO
End Date Time:
Nov/5/2020 08:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  Axillary lymphadenopathy
on the left. Jan/20/2021 UN
K:UNK NO
End Date Time:
Jan/23/2021 UNK:UN
K
 Repeating
Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846186
Page 36 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12101029 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)[joint pain]
4.Start Date Time: Nov/4/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/5/2020 08:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[ride motorcycle]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846187
Page 37 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846188
Page 38 of 225
***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: 12101029 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)[Axillary lymphadenopathy on the left.]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846189
Page 39 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846190
Page 40 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846191
Page 41 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error
associated with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846192
Page 42 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846193
Page 43 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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.Date: Not Applicable
//Comments
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846194
Page 44 of 225
***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: 12101029 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.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applica
ble Repeating
Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846195
Page 45 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
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: 12101029 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.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846196
Page 46 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846197
Page 47 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846198
Page 48 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846199
Page 49 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846200
Page 50 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846201
Page 51 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: UNPLANNED VISIT
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846202
Page 52 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12101029 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:
Nov/5/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [patient had joint pain which was started on 04 Nov 2020. Patient rides
motorcycle in his daily life. Investigator evaluated this event as not
reactogenecity. Joint pain recovered on 05 Nov 2020.]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846203
Page 53 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846204
Page 54 of 225
***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: 12101029 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:
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846205
Page 55 of 225
***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: 12101029 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?
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846206
Page 56 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846207
Page 57 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846208
Page 58 of 225
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Dec/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846209
Page 59 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846210
Page 60 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846211
Page 61 of 225
***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: 12101029 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: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846212
Page 62 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846213
Page 63 of 225
***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: 12101029 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
Dec/29/2020
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846214
Page 64 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846215
Page 65 of 225
***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: 12101029 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 :Dec/29/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846216
Page 66 of 225
***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: 12101029 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/29/2020
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 [BR5DM4]
5.bSample ID [BR5DM5]
5.cSample ID [BSHB8X]
5.dSample ID [BSHB8Y]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846217
Page 67 of 225
***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: 12101029 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/29/2020
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 [BR5DMB]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846218
Page 68 of 225
***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: 12101029 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: Dec/29/2020 14:25
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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846219
Page 69 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/28/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846220
Page 70 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846221
Page 71 of 225
***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: 12101029 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
[ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846222
Page 72 of 225
***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: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846223
Page 73 of 225
***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: 12101029 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/19/2021
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 [BR0Z02]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846224
Page 74 of 225
***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: 12101029 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/19/2021 09:55
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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846225
Page 75 of 225
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846226
Page 76 of 225
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12101029 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:
Feb/16/2021
3.Comments: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846227
Page 77 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846228
Page 78 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846229
Page 79 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846230
Page 80 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846231
Page 81 of 225
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Feb/16/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846232
Page 82 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/18/2020
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846233
Page 83 of 225
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846234
Page 84 of 225
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ali Mert  Approved Feb-16-2021 15:08:47 (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.
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846235
Page 85 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 19:25:54 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846236
Page 86 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 19:26:28 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846237
Page 87 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846238
Page 88 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846239
Page 89 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846240
Page 90 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846241
Page 91 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846242
Page 92 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846243
Page 93 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846244
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***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846245
Page 95 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846246
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***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846247
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***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Nov-05-2020 13:40:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846248
Page 98 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
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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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846249
Page 99 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
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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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846250
Page 100 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846251
Page 101 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846252
Page 102 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846253
Page 103 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-05-2020 13:41:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846254
Page 104 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846255
Page 105 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846256
Page 106 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846257
Page 107 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846258
Page 108 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846259
Page 109 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846260
Page 110 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846261
Page 111 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846262
Page 112 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846263
Page 113 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846264
Page 114 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Nov-05-2020 13:41:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846265
Page 115 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846266
Page 116 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846267
Page 117 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846268
Page 118 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846269
Page 119 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846270
Page 120 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846271
Page 121 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-05-2020 13:41:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846272
Page 122 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:42:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846273
Page 123 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:42:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846274
Page 124 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:42:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846275
Page 125 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-30-2020 15:40:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846276
Page 126 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 16:31:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846277
Page 127 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 16:31:43 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846278
Page 128 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-29-2020 16:32:03 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846279
Page 129 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-29-2020 16:32:03 (UTC+03:00) Istanbul Not Applicable
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0846280
Page 130 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ali Mert  Approved Feb-16-2021 15:08:47 (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.
 N/A Feb-16-2021 14:08:05 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Feb-03-2021 16:36:29 (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 Feb-02-2021 13:50:51 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Feb-02-2021 11:35:57 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846281
Page 131 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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 Jan-27-2021 09:29:00 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-22-2021 17:55:06 (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-22-2021 12:35:23 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-19-2021 15:06:14 (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.
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846282
Page 132 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Jan-19-2021 12:15:42 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Jan-05-2021 16:55:32 (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-29-2020 12:07:30 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Dec-22-2020 13:56:54 (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 12:33:47 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-25-2020 13:49:58 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846283
Page 133 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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-20-2020 10:49:25 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ali Mert  Approved Nov-05-2020 13:53:08 (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-05-2020 13:40:01 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-03-2020 17:18:18 (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.
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846284
Page 134 of 225
***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: 12101029 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 19:24:45
(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 19:24:45
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846285
Page 135 of 225
***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: 12101029 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 19:24:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/30/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846286
Page 136 of 225
***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: 12101029 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 19:24:35
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12101029Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 19:24:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1983Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020 19:28:59
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
MALETranscription Error
Oct-30-2020 19:25:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-30-2020 19:25:10
(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 19:25:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fe0\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846287
Page 137 of 225
***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: 12101029 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 19:25:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846288
Page 138 of 225
***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: 12101029 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 19:26:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 19:26:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 19:26:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846289
Page 139 of 225
***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: 12101029 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 19:26:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846290
Page 140 of 225
***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: 12101029 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 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
105.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.1Initial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846291
Page 141 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Oct-30-2020 19:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locati
on::FOREHE
ADTranscription Error
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.0
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020 19:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-30-2020 19:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.1Transcription Error
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 36 C is
outside of Normal
Range 36.1 - 37.5 C.
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.0Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846292
Page 142 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020 19:28:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846293
Page 143 of 225
***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: 12101029 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 19:30:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020 19:30:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
114945Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846294
Page 144 of 225
***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: 12101029 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 19:30:47
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 19:30:47
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 19:33:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 19:30:47
(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 19:30:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 19:33:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB2ZInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846295
Page 145 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-30-2020 19:33:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB2ZInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 19:33:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB30Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 19:33:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB30Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 19:33:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXNMInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 19:33:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRCXNMInitial Entry
5.d
Date Location User Value Reason
Oct-30-2020 19:34:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXNNInitial Entry
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846296
Page 146 of 225
***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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 19:34:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRCXNNInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846297
Page 147 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 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 19:31:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 19:31:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 19:33:09
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Oct-30-2020 19:32:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 19:32:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-30-2020 19:31:49
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened There are more than
1 barcode present
for sample
collection. Please
review and correct
as appropriate.
Oct-30-2020 19:31:34
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 19:31:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0846298
Page 148 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
as appropriate.
Oct-30-2020 19:31:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 19:32:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB2ZTranscription Error
(DELETED)
Oct-30-2020 19:31:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB2ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 19:32:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB2ZTranscription Error
(DELETED)
Oct-30-2020 19:31:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB2ZInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 19:32:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB30Transcription Error
(DELETED)
Oct-30-2020 19:31:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB30Initial Entry
090177e196ae2fe0\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) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846299
Page 149 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 19:32:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB30Transcription Error
(DELETED)
Oct-30-2020 19:31:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB30Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 19:33:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXP3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 19:33:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRCXP3Initial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846300
Page 150 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020 15:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fe0\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-2021-5683-0846301
Page 151 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-30-2020 19:34:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846302
Page 152 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-30-2020 19:35:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846303
Page 153 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-20-2020 10:49:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846304
Page 154 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846305
Page 155 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
UE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae2fe0\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-2021-5683-0846306
Page 156 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846307
Page 157 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846308
Page 158 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846309
Page 159 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846310
Page 160 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846311
Page 161 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-20-2020 10:49:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846312
Page 162 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2.a
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846313
Page 163 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-20-2020 10:50:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846314
Page 164 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-20-2020 10:51:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-20-2020 10:51:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-20-2020 10:51:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 10:51:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-20-2020 10:51:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-20-2020 10:51:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR5DKXInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846315
Page 165 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-20-2020 10:51:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5DKXInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846316
Page 166 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/20/2020 10:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fe0\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-2021-5683-0846317
Page 167 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-20-2020 10:52:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846318
Page 168 of 225
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 12:33:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846319
Page 169 of 225
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846320
Page 170 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
UE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae2fe0\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-2021-5683-0846321
Page 171 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846322
Page 172 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846323
Page 173 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846324
Page 174 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846325
Page 175 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846326
Page 176 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-18-2020 12:35:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846327
Page 177 of 225
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 12:35:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 12:35:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 15:26:57
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-18-2020 12:59:20
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 12:35:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 12:35:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846328
Page 178 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-18-2020 15:26:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXWCInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 15:26:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRCXWCInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 15:27:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRCXWDInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 15:27:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRCXWDInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 15:27:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB6RInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 15:27:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB6RInitial Entry
5.d
Date Location User Value Reason
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846329
Page 179 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-18-2020 15:27:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB6SInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-18-2020 15:27:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB6SInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846330
Page 180 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846331
Page 181 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846332
Page 182 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-09-2020
10:52:00
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1:
ClosedResponse
satisfies query
Nov-06-2020
18:30:44
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1:
AnsweredAs it was not
evaluated as
reactogenicity,
it was entered
as adverse.
Nov-06-2020
13:45:18
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedeDiary: AE
Joint pain
reported with
start date
04-Nov-2020
and End Date
05-Nov-2020
seems to be
same as
e-Diary
occurence Joint
pain reported
on
04-Nov-2020.
Please
reconcile or
confirm in the
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0846333
Page 183 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
query response
as appropriate
Nov-05-2020
13:40:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entr
y:
joint painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/4/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/5/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846334
Page 184 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
ride motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846335
Page 185 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020 13:40:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846336
Page 186 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-29-2021 05:32:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-27-2021 09:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-27-2021 09:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Axillary lymphadenopathy on the
left.Transcription Error
Jan-26-2021 21:45:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please add
information on the
laterality, e.g., left,
right, or both sides.
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Axillary lymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/20/2021 UNK:UNKInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0846337
Page 187 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021 13:50:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/23/2021 UNK:UNKNew Information
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846338
Page 188 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-02-2021 13:51:15
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-02-2021 13:51:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-02-2021 13:50:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Axillary
lymphadenopathy on
the left.: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846339
Page 189 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021 12:35:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846340
Page 190 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846341
Page 191 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-05-2020 13:40:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846342
Page 192 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-05-2020 13:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-05-2020 13:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-05-2020 13:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Nov-05-2020 13:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Nov-05-2020 13:41:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846343
Page 193 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846344
Page 194 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Nov-05-2020 13:41:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\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)
FDA-CBER-2021-5683-0846345
Page 195 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Nov-05-2020 13:41:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846346
Page 196 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Nov-05-2020 13:42:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Nov-05-2020 13:42:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846347
Page 197 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: DATE OF VISIT - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 13:42:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846348
Page 198 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Nov-05-2020 13:50:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 13:42:57
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update
as appropriate.
Nov-05-2020 13:42:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846349
Page 199 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/05/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Nov-05-2020 13:50:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Nov-05-2020 13:50:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Nov/5/2020
Contact Outcome:
VISIT NOT ARRANGED, RE
ACTION NO LONGER PRES
ENTInitial Entry
3. Comments:
Date Location User Value Reason
Nov-05-2020 13:50:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
patient had joint pain which was st
arted on 04 Nov 2020. Patient ride
s motorcycle in his daily life. Inve
stigator evaluated this event as not
reactogenecity. Joint pain recovere
d on 05 Nov 2020.Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846350
Page 200 of 225
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-18-2020 16:51:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 16:51:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 16:51:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846351
Page 201 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-29-2020 12:07:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846352
Page 202 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-29-2020 16:31:28
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-29-2020 12:35:13
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-29-2020 12:07:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Dec-29-2020 12:07:39
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-29-2020 12:07:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2fe0\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-2021-5683-0846353
Page 203 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-30-2020 15:40:13
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/29/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846354
Page 204 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-30-2020 15:40:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/29/2020Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846355
Page 205 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-30-2020 15:41:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-30-2020 15:41:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-30-2020 15:41:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846356
Page 206 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020 15:41:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020 15:41:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020 15:42:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-30-2020 15:41:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-30-2020 15:41:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/29/2020Initial Entry
5.a
Date Location User Value Reason
Dec-30-2020 15:42:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR5DM4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846357
Page 207 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-30-2020 15:42:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5DM4Initial Entry
5.b
Date Location User Value Reason
Dec-30-2020 15:42:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR5DM5Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-30-2020 15:42:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5DM5Initial Entry
5.c
Date Location User Value Reason
Dec-30-2020 15:42:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB8XInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-30-2020 15:42:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB8XInitial Entry
5.d
Date Location User Value Reason
Dec-30-2020 15:43:04
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHB8YInitial Entry
090177e196ae2fe0\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) (4)
FDA-CBER-2021-5683-0846358
Page 208 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Dec-30-2020 15:43:04
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHB8YInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846359
Page 209 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020 15:43:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020 15:43:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020 15:43:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-30-2020 15:43:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-30-2020 15:43:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/29/2020Initial Entry
5.a
Date Location User Value Reason
Dec-30-2020 15:43:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR5DMBInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846360
Page 210 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-30-2020 15:43:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5DMBInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846361
Page 211 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/29/2020 14:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fe0\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-2021-5683-0846362
Page 212 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-30-2020 15:49:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846363
Page 213 of 225
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-29-2020 16:31:28
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-29-2020 16:31:28
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846364
Page 214 of 225
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Dec-29-2020 16:31:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846365
Page 215 of 225
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Collection / Notification of Death:
Date Location User ValueReason
Jan-06-2021
09:42:22
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
1: Clo
sedQuery raised in error
Dec-31-2020
13:33:24
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6657961;Date
of
Collection/Notification
of Death is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Dec-29-2020
16:32:03
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0846366
Page 216 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 12:15:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846367
Page 217 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 12:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 12:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 12:16:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 12:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 12:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 12:16:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR0Z02Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846368
Page 218 of 225
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1210 Site Name: (1210) Medipol University Medical Faculty
Subject No: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-19-2021 12:16:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR0Z02Initial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846369
Page 219 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/19/2021 09:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fe0\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-2021-5683-0846370
Page 220 of 225
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 12101029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-19-2021 13:06:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe0\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0846371
Page 221 of 225
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF
…[truncated]