125742 S1 M5 CRF c4591001 1217 12171039

Document text

Page 1 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822132
Page 2 of 250
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/4/2020
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822133
Page 3 of 250
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [12171039]
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:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822134
Page 4 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822135
Page 5 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822136
Page 6 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathNov/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822137
Page 7 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypercholesterol]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822138
Page 8 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822139
Page 9 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
2.Weight: [75.0]
3.Unit: kg
4.Height: [176.0]
5.Unit: cm
6.Body Mass Index: [24.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: FOREHEAD
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822140
Page 10 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/4/2020
2.Randomization Number: [115336]
3.Randomization Group: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822141
Page 11 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BPZ96Y]
5.bSample ID [BPZ96Z]
5.cSample ID [BS2S40]
5.dSample ID [BS2S41]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822142
Page 12 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BPZ9F7]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822143
Page 13 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/4/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822144
Page 14 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822145
Page 15 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/25/2020
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822146
Page 16 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?YES
Ongoing?
NO
Stop Date:
Nov/10/2020
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822147
Page 17 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822148
Page 18 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822149
Page 19 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822150
Page 20 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR510Z]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822151
Page 21 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/25/2020 10:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822152
Page 22 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822153
Page 23 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822154
Page 24 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822155
Page 25 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822156
Page 26 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
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 [BPZ9BX]
5.bSample ID [BPZ9BY]
5.cSample ID [BS2S6X]
5.dSample ID [BS2S6Y]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822157
Page 27 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822158
Page 28 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822159
Page 29 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822160
Page 30 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822161
Page 31 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822162
Page 32 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822163
Page 33 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822164
Page 34 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822165
Page 35 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822166
Page 36 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822167
Page 37 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Tinnitus in right
ear Jan/8/2021 U
NK:UNK NO
End Date Time:
Jan/18/2021 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  Acute hearing l
oss in right ear Jan/UNK/202
1 UNK:UNK NO
End Date Time:
Jan/18/2021 UN
K:UNK
 Repeating
Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822168
Page 38 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[Tinnitus in right ear]
4.Start Date Time: Jan/8/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/18/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822169
Page 39 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822170
Page 40 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822171
Page 41 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Acute hearing loss in right ear]
4.Start Date Time: Jan/UNK/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/18/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822172
Page 42 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822173
Page 43 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822174
Page 44 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822175
Page 45 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822176
Page 46 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822177
Page 47 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822178
Page 48 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defi
ned Identifie
rCategory fo
r Medicatio
nConcomitant Medi
cations Pre-specifi
edName of Medi
cationDose De
scriptio
nForm Insta
nce
 1.1  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 20  Repeating
Pages
 2.2  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 16  Repeating
Pages
 3.3  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 16  Repeating
Pages
 4.4  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 16  Repeating
Pages
 5.5  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 16  Repeating
Pages
 6.6  CORTICOS
TEROIDS NO  Prednol (meth
ylprednisolone
) 8  Repeating
Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822179
Page 49 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [20]
6.Dose Unit: mg
7.Dose Frequency: QID
8.Route: ORAL
9.Start Date: Jan/15/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822180
Page 50 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Jan/17/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822181
Page 51 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [16]
6.Dose Unit: mg
7.Dose Frequency: QID
8.Route: ORAL
9.Start Date: Jan/18/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822182
Page 52 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Jan/20/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822183
Page 53 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[3]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [16]
6.Dose Unit: mg
7.Dose Frequency: TID
8.Route: ORAL
9.Start Date: Jan/21/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822184
Page 54 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Jan/23/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822185
Page 55 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[4]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [16]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: ORAL
9.Start Date: Jan/24/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822186
Page 56 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Jan/26/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822187
Page 57 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[5]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [16]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Jan/27/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822188
Page 58 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Jan/29/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822189
Page 59 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[6]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Prednol (methylprednisolone)]
5.Dose: [8]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Jan/30/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822190
Page 60 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Ongoing? NO
End Date:
Feb/1/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822191
Page 61 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822192
Page 62 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822193
Page 63 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822194
Page 64 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822195
Page 65 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822196
Page 66 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822197
Page 67 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822198
Page 68 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822199
Page 69 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822200
Page 70 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822201
Page 71 of 250
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822202
Page 72 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822203
Page 73 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822204
Page 74 of 250
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822205
Page 75 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822206
Page 76 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822207
Page 77 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822208
Page 78 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
[ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822209
Page 79 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822210
Page 80 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/3/2021
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822211
Page 81 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822212
Page 82 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822213
Page 83 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BN897X]
5.bSample ID [BN897Y]
5.cSample ID [BS2S9P]
5.dSample ID [BS2S9R]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822214
Page 84 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BN897W]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822215
Page 85 of 250
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: Mar/3/2021 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822216
Page 86 of 250
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822217
Page 87 of 250
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822218
Page 88 of 250
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822219
Page 89 of 250
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822220
Page 90 of 250
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822221
Page 91 of 250
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822222
Page 92 of 250
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822223
Page 93 of 250
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822224
Page 94 of 250
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822225
Page 95 of 250
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822226
Page 96 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/23/2020
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822227
Page 97 of 250
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822228
Page 98 of 250
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sila Akhan  Approved Mar-03-2021 12:16:26 (UTC+03:00)
IstanbulBOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822229
Page 99 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-04-2020 09:12:51 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822230
Page 100 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormFeb-10-2021 14:02:55 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822231
Page 101 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Feb-10-2021 14:02:55 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822232
Page 102 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormFeb-10-2021 14:03:14 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822233
Page 103 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Feb-10-2021 14:03:14 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822234
Page 104 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormMar-03-2021 11:02:23 (UTC+03:00)
IstanbulNot Applicable
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822235
Page 105 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sila Akhan  Approved Mar-03-2021 12:16:26 (UTC+03:00)
IstanbulBOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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 Mar-03-2021 11:02:01 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Feb-10-2021 14:15:23 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822236
Page 106 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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-10-2021 14:02:42 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Feb-03-2021 16:23:28 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822237
Page 107 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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-03-2021 16:02:02 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-22-2021 22:24:30 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822238
Page 108 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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 22:17:53 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-22-2021 16:27:22 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822239
Page 109 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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 16:02:54 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-20-2021 15:30:13 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822240
Page 110 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-19-2021 15:53:24 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-19-2021 13:30:57 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822241
Page 111 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-19-2021 13:18:48 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Dec-23-2020 12:21:41 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822242
Page 112 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Dec-23-2020 12:01:57 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Dec-02-2020 20:58:20 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822243
Page 113 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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-19-2020 16:00:45 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Nov-18-2020 09:27:28 (UTC+03:00)
IstanbulBOOK Signed
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822244
Page 114 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822245
Page 115 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-04-2020
08:56:36
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-04-2020
08:56:36
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822246
Page 116 of 250
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-04-2020
08:56:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Nov/4/2020Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822247
Page 117 of 250
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-04-2020
08:56:23
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12171039Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Nov-04-2020
08:56:16
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1983Enrollment
Entry
3. Sex:
Date Location User Value Reason
Nov-04-2020
08:57:59
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-04-2020
08:57:59ACV0PFEINFP6000  Data Entry:
NOT HISPANIC ORInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822248
Page 118 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulLATINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-04-2020
08:57:59
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822249
Page 119 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-04-2020
09:12:40
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822250
Page 120 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-04-2020
09:13:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-04-2020
09:13:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-04-2020
09:13:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822251
Page 121 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Nov-04-2020
10:21:32
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:hyperch
olestero
l
Start Date: Jan/UN
K/2020
Ongoing: YESChanged
Information
Nov-04-2020
10:20:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:hyperch
olestero
l
Start Date: UNK/U
NK/201
9
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822252
Page 122 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Nov-04-2020
10:20:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020
10:20:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
hypercholesterolInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-04-2020
10:21:32
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Changed
Information
Nov-04-2020
10:20:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-04-2020
10:20:39
(UTC+03:00)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822253
Page 123 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Istanbul
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822254
Page 124 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-04-2020
09:13:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822255
Page 125 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
75.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822256
Page 126 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10:09:17
(UTC+03:00)
Istanbul176.0
5. Unit:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.2Initial Entry
7.a
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperature
:37.1
Temperature
Unit:CInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822257
Page 127 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Temperature
Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822258
Page 128 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Nov-04-2020
10:09:17
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822259
Page 129 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-04-2020
15:28:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-04-2020
15:28:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
115336Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822260
Page 130 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020
15:03:56
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020
15:03:56
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020
15:27:05
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-04-2020
15:03:56
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822261
Page 131 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Nov-04-2020
15:03:56
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020
15:27:05
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZ96YInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020
15:27:05
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BPZ96YInitial Entry
5.b
Date Location User Value Reason
Nov-04-2020
15:27:18
(UTC+03:00)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ96ZInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822262
Page 132 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Istanbul
5.b Sample ID
Date Location User Value Reason
Nov-04-2020
15:27:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BPZ96ZInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020
16:00:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BS2S40Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020
16:00:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BS2S40Initial Entry
5.d
Date Location User Value Reason
Nov-19-2020
16:00:58ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822263
Page 133 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulSample ID: BS2S41
5.d Sample ID
Date Location User Value Reason
Nov-19-2020
16:00:58
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BS2S41Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822264
Page 134 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020
15:27:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020
15:27:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020
15:27:55
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-04-2020
15:27:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822265
Page 135 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Nov-04-2020
15:27:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020
15:27:55
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZ9F7Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020
15:27:55
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BPZ9F7Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822266
Page 136 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-04-2020
15:28:42ACV0PFEINFP6000  Data Entry:
Nov/4/2020 09:50Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822267
Page 137 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
Istanbul
5. Anatomical Location:
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-04-2020
15:28:42ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822268
Page 138 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-04-2020
15:28:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822269
Page 139 of 250
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-04-2020
10:34:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS
SUBJECTInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822270
Page 140 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-25-2020
10:11:03
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822271
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822272
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822273
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.b Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822274
Page 144 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:YES
Ongoin
g?
NO
Stop
Dat
e:
No
v/
10
/2
02
0
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822275
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.c Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Nov/10/2020Initial Entry
2.d
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LSInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822276
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
O
2.d Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TIInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822277
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
NG
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NO
2.e Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
ARInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822278
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Istanbul RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NO
2.f Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-25-2020
10:12:45ACV0PFEINFP6000  Data Entry:
Symptom:: NEWInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822279
Page 149 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulOR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE 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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822280
Page 150 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.h
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822281
Page 151 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.h Symptom:
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-25-2020
10:13:32
(UTC+03:00)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822282
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Istanbul
5.a
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was complet
ed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822283
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
Istanbul
5.b
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822284
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822285
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***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-25-2020
10:12:45
(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-25-2020
10:12:45
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822286
Page 156 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
2.a
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperature
:36.3
Temperature
Unit:C
Temperature
Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822287
Page 157 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.a Temperature:
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-25-2020
10:13:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822288
Page 158 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020
10:14:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020
10:14:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-25-2020
11:16:40
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-25-2020
10:14:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822289
Page 159 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Nov-25-2020
10:14:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/25/2020Initial Entry
5.a
Date Location User Value Reason
Nov-25-2020
11:16:40
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR510ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020
11:16:40
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BR510ZInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822290
Page 160 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-25-2020
11:17:25ACV0PFEINFP6000  Data Entry:
Nov/25/2020 10:30Changed
Information
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822291
Page 161 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
Istanbul
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Nov/25/2020 10:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-25-2020
11:17:41
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822292
Page 162 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-25-2020
10:16:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822293
Page 163 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020
12:01:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Dec/23/2020Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822294
Page 164 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822295
Page 165 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822296
Page 166 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.b Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822297
Page 167 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.c Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822298
Page 168 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.d Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822299
Page 169 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.e Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822300
Page 170 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.f Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822301
Page 171 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE 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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-23-2020
12:02:18ACV0PFEINFP6000  Data Entry:
Symptom:: NEWInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822302
Page 172 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulOR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822303
Page 173 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
3. Injection Site Location:
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-23-2020
12:02:35
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was complet
ed?:N
OInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822304
Page 174 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822305
Page 175 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822306
Page 176 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-23-2020
12:02:18
(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-23-2020
12:02:18
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822307
Page 177 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020
12:02:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020
12:02:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020
12:03:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-23-2020
12:02:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822308
Page 178 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Dec-23-2020
12:02:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020
12:03:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZ9BXInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-23-2020
12:03:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BPZ9BXInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020
12:04:04
(UTC+03:00)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ9BYInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822309
Page 179 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Istanbul
5.b Sample ID
Date Location User Value Reason
Dec-23-2020
12:04:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BPZ9BYInitial Entry
5.c
Date Location User Value Reason
Dec-23-2020
12:04:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BS2S6XInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-23-2020
12:04:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BS2S6XInitial Entry
5.d
Date Location User Value Reason
Dec-23-2020
12:04:53ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822310
Page 180 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
IstanbulSample ID: BS2S6Y
5.d Sample ID
Date Location User Value Reason
Dec-23-2020
12:04:53
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BS2S6YInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822311
Page 181 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822312
Page 182 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822313
Page 183 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021
13:18:48
(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
Jan-22-2021
16:39:52
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-22-2021
16:02:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered data is updated
as per query
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822314
Page 184 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Jan-22-2021
16:02:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Tinnitus in right eardata is updated
as per query
Jan-22-2021
15:57:50
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Reissued:
Openedclinical:
thanks, but if
tinnitus in the
R ear only, pls
update AE
term to reflect
this.
Jan-22-2021
15:47:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Answered the volunteer
experienced
hearing loss in
the right ear
only
Jan-22-2021
14:43:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Opened clinical: pls
update term to
indicate if
right, left or
both ears.
Thanks
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
tinnitusInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0822315
Page 185 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/8/2021 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/18/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
1Initial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822316
Page 186 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-19-2021
13:18:48
(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-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822317
Page 187 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822318
Page 188 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021
13:18:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822319
Page 189 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021
15:53:24
(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
Feb-08-2021
00:53:59
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Feb-06-2021
15:12:40
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Answere
dThe volunteer
has no known
history.
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822320
Page 190 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Feb-05-2021
19:19:15
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Opened clinical: pls
confirm subject
has no past
history of
hearing loss,
episodes of
hearing loss,
tinnitis or other
ear problems or
update MedHx
CRF
accordingly.
Thanks
Jan-24-2021
19:24:50
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Jan-23-2021
12:34:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Answere
dAs a result of
the test
conducted on
January 18,
2021, it was
stated that the
hearing loss
returned to
normal.
Jan-23-2021
01:24:15
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Reissued
:Openedclinical: pls
confirm,
hearing on
repeat
audiometry was
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822321
Page 191 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
back to normal?
was the hearing
loss determined
to be
sensorineural or
not? Thanks
Jan-22-2021
22:42:37
(UTC+03:00)
IstanbulACV0PFEINFP6000  Binnur
YildirimQuery 2: Answere
dComplaints in
repeated
audiometry on
January 18
ended.
Jan-22-2021
22:24:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Reissued
:Openedclinical:
Thanks, but pls
advise if
audiometry
revealed
sensorineural
hearing loss
and if there was
any
improvement
on the repeat
audiometry
done 18 Jan.
Jan-22-2021
22:19:08
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Acute hearing loss
in right earChanged
Information
Jan-22-2021
22:17:53ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dChanged
Information
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822322
Page 192 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC+03:00)
Istanbul
Jan-22-2021
22:17:53
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Acute hearing lossChanged
Information
Jan-22-2021
16:44:36
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Closed reissued
Jan-22-2021
16:44:25
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Opened clinical:
Thanks, but pls
update AE term
to indicate
which ear(s)
affected and
advise if
hearing has
improved on
repeat
audiometry, and
update AE term
to indicate if
sensorineural or
conductive
hearing loss
Jan-22-2021
16:42:22
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Reissued
:Openedclinical:
Thanks, but pls
update AE term
to indicate
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822323
Page 193 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
which ear(s)
affected and
advise if
hearing has
improved on
repeat
audiometry.
Jan-22-2021
16:14:15
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Answere
dControl
audiometry
refers to pure
tone
audiometry for
right ear.
Subject started
to take prednol
16 mg PO 5x1
on 15Jan2021.
Medication is
still ongoing
but dose is
decreasing day
by day.But AE
was terminated
according to the
control test.
Jan-22-2021
14:41:21
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Reissued
:Openedclinical: pls
update AE term
to indicate
whether R, L or
both ears
involved. Pls
clarify what
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822324
Page 194 of 250
***Confidential***
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History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
'control
audiometry'
refers to, and
the severity of
hearing loss on
the audiometry.
Has subject
received any
treatment or
improvement?
Jan-22-2021
11:40:59
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Answere
dSubject was
seen ENT on
15Jan2021 and
an audiometry
was performed.
According to
the result, acute
hearing loss
was diagnosed.
Then control
audiometry was
performed on
18Jan2021. AE
was closed
Jan-21-2021
18:33:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Opened clin: pls
confirm no
prior hx
tinnitus,
hearing issues.
Advise how dx
made ie
subjective vs
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822325
Page 195 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
audiometry,
degree of
hearing loss,
and has subject
seen ENT?
Thanks
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
sudden hearing los
sInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-26-2021
18:28:09
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Jan-26-2021
10:59:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Answered the date of
onset of
hearing loss
is unknown.
Jan-25-2021
19:16:50
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Opened clinical: pls
enter start
DAY. Thanks
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/UNK/2021 UN
K:UNKInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0822326
Page 196 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/18/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
1Initial 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-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822327
Page 197 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
00:42:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-06-2021
15:17:55
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Answered Acute hearing
loss
Feb-05-2021
19:19:34
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Opened clinical:
causality is
listed as
non-related,
other =UNK.
Please provide
specific
causality if
possible.
Thanks
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0822328
Page 198 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Jan-19-2021
15:54:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s)
, this event is due
to:
OTHER
If Other, specif
y:
UnknownTranscription
Error
Jan-19-2021
15:54:25
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATEDTranscription
Error
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822329
Page 199 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021
15:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822330
Page 200 of 250
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822331
Page 201 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
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Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822332
Page 202 of 250
***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822333
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***Confidential***
Header Text: c4591001
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Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822334
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***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822335
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***Confidential***
Header Text: c4591001
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Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822336
Page 206 of 250
***Confidential***
Header Text: c4591001
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822337
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***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
00:58:46
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822338
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:07:26
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
20New
Information
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
80Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:07:41
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
QIDNew
Information
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
TIDInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0822339
Page 209 of 250
***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
8. Route:
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:02:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/17/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822340
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***Confidential***
 
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822341
Page 211 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
00:59:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822342
Page 212 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:08:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
16New
Information
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
64Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:08:13
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
QIDChanged
Information
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
TIDInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0822343
Page 213 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
8. Route:
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:04:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/20/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822344
Page 214 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822345
Page 215 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
00:59:16
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822346
Page 216 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:05:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
16Transcription
Error
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
48Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
TIDInitial Entry
8. Route:
Date Location User Value Reason
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822347
Page 217 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:05:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/23/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822348
Page 218 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822349
Page 219 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
00:59:29
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822350
Page 220 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
16Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
BIDInitial Entry
8. Route:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822351
Page 221 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/24/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:09:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/26/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822352
Page 222 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822353
Page 223 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
00:59:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822354
Page 224 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
16Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822355
Page 225 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:10:01
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/29/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822356
Page 226 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
2. Category:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial 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).
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822357
Page 227 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-12-2021
01:16:02
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Deleted Query is invalid
or does not
apply
Feb-12-2021
01:00:09
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1: Candidat
eCLINQUERY:
Per Protocol
Section 6.5.1.
Prohibited
During the
Study - Receipt
of Systemic
Corticosteroids
(≥20 mg/day of
prednisone or
equivalent) for
≥14 days is
prohibited. This
ConMed
Record does not
meet this
Criteria. Please
confirm and
DELETE
Record.
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Prednol (methylpr
ednisolone)Initial Entry
5. Dose:
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822358
Page 228 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
8Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
ORALInitial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822359
Page 229 of 250
***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, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
9. Start Date:
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-03-2021
16:21:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/1/2021Initial Entry
090177e196d89024\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822360
Page 230 of 250
***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: 1217 Site Name: (1217) Kocaeli University Faculty of
Medicine
Subject No: 12171039 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
…[truncated]