Document text
Page 1 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821931
Page 2 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/30/2020
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821932
Page 3 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12171031]
2.Birth Date: 1985
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821933
Page 4 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821934
Page 5 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821935
Page 6 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821936
Page 7 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821937
Page 8 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821938
Page 9 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/30/2020
2.Weight: [65.0]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [27.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821939
Page 10 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821940
Page 11 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/30/2020
2.Randomization Number: [114923]
3.Randomization Group: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821941
Page 12 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ96W]
5.bSample ID [BPZ96X]
5.cSample ID [BS2S3V]
5.dSample ID [BS2S3W]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821942
Page 13 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ96H]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821943
Page 14 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/30/2020 11:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821944
Page 15 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821945
Page 16 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821946
Page 17 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821947
Page 18 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821948
Page 19 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821949
Page 20 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821950
Page 21 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BPZ9GX]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821951
Page 22 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Nov/19/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Done Comments
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?Not Done Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821952
Page 23 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821953
Page 24 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821954
Page 25 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821955
Page 26 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BPZ9CV]
5.bSample ID [BPZ9CW]
5.cSample ID [BNLZT7]
5.dSample ID [BNLZT8]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821956
Page 27 of 201
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821957
Page 28 of 201
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821958
Page 29 of 201
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821959
Page 30 of 201
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821960
Page 31 of 201
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821961
Page 32 of 201
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821962
Page 33 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821963
Page 34 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821964
Page 35 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821965
Page 36 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821966
Page 37 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821967
Page 38 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821968
Page 39 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821969
Page 40 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821970
Page 41 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821971
Page 42 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821972
Page 43 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 exposure during pregn
ancy Oct/30/2020 11
:55 YES Repeating
Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821973
Page 44 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[exposure during pregnancy]
4.Start Date Time: Oct/30/2020 11:55 Comments
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
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 Comments
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:
[subject pregnant]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821974
Page 45 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13.What was the outcome of this
adverse event?:UNKNOWN Comments
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ] Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821975
Page 46 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821976
Page 47 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821977
Page 48 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medicat
ionStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Hepatitis A Vacci
nation Nov/9/20
20 Repeating
Pages
2.2 VACCINATIONS NO Hepatitis B Vacci
nation Nov/9/20
20 Repeating
Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821978
Page 49 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Hepatitis A Vaccination]
5.Date: Nov/9/2020
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821979
Page 50 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Hepatitis B Vaccination]
5.Date: Nov/9/2020
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821980
Page 51 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821981
Page 52 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821982
Page 53 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821983
Page 54 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821984
Page 55 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821985
Page 56 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821986
Page 57 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821987
Page 58 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: UNPLANNED VISIT
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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821988
Page 59 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Nov/3/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821989
Page 60 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821990
Page 61 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821991
Page 62 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821992
Page 63 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821993
Page 64 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821994
Page 65 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821995
Page 66 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821996
Page 67 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821997
Page 68 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821998
Page 69 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821999
Page 70 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/7/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822000
Page 71 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822001
Page 72 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822002
Page 73 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822003
Page 74 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822004
Page 75 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822005
Page 76 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822006
Page 77 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/7/2020
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822007
Page 78 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822008
Page 79 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sila Akhan Approved Jan-21-2021 13:29:41 (UTC+03:00) Istanbul BOOK 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.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822009
Page 80 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 15:03:59 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822010
Page 81 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 15:43:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822011
Page 82 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-24-2020 14:44:01 (UTC+03:00) Istanbul This secton will be enter
Not Done
4Nov-24-2020 14:43:22 (UTC+03:00) Istanbul This secton will be enter
4Nov-24-2020 14:40:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822012
Page 83 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-24-2020 14:43:38 (UTC+03:00) Istanbul This secton will be enter
Not Done
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822013
Page 84 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
11Nov-24-2020 14:44:17 (UTC+03:00) Istanbul This secton will be enter
Not Done
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822014
Page 85 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822015
Page 86 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822016
Page 87 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822017
Page 88 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.bDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822018
Page 89 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.cDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822019
Page 90 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.dDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822020
Page 91 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.eDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822021
Page 92 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 fDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822022
Page 93 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.gDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822023
Page 94 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 hDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822024
Page 95 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822025
Page 96 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822026
Page 97 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822027
Page 98 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822028
Page 99 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-17-2020 13:37:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822029
Page 100 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-16-2020 16:47:43 (UTC+03:00) Istanbul Binnur Yildirim The AE date was updated according to DM request
;CCG page184 "In the absence of ultrasound, the
data from the last menstrual period (LMP) should
be used to estimate date of conception". So the AE
date updated according to LMP.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822030
Page 101 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-09-2020 19:58:56 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822031
Page 102 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Dec-14-2020 16:02:44 (UTC+03:00) Istanbul The AE "exposure during pregnancy" has already
submitted as SAE to sponsor. This is a SAE per
protocol due to Subject is pregnant. This is an
important medical event, however subject does not
meet other options.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822032
Page 103 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
13Dec-18-2020 15:06:59 (UTC+03:00) Istanbul Binnur Yildirim data was changed according to the 'the latest EDP
guidance, outcome should be recorded as
UNKNOWN'.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822033
Page 104 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
15Dec-08-2020 16:05:21 (UTC+03:00) Istanbul Binnur Yildirim 2020484307
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822034
Page 105 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 18:51:04 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not
applicable for this subject.
Not Applicable
FormJan-20-2021 18:48:00 (UTC+03:00) Istanbul
FormJan-20-2021 18:38:46 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not
applicable for this subject.
Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822035
Page 106 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-20-2021 18:51:04 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
1Jan-20-2021 18:48:00 (UTC+03:00) Istanbul
1Jan-20-2021 18:38:46 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822036
Page 107 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-20-2021 18:51:04 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
2Jan-20-2021 18:48:00 (UTC+03:00) Istanbul
2Jan-20-2021 18:38:46 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822037
Page 108 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 18:51:45 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not
applicable for this subject.
Not Applicable
FormJan-20-2021 18:49:05 (UTC+03:00) Istanbul
FormJan-20-2021 18:39:44 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not
applicable for this subject.
Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822038
Page 109 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-20-2021 18:51:45 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
1Jan-20-2021 18:49:05 (UTC+03:00) Istanbul
1Jan-20-2021 18:39:44 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
1Jan-15-2021 15:12:01 (UTC+03:00) Istanbul
1Jan-15-2021 15:10:32 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822039
Page 110 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-20-2021 18:40:04 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not
applicable for this subject.
Not Applicable
FormJan-20-2021 17:20:03 (UTC+03:00) Istanbul
FormJan-15-2021 15:12:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822040
Page 111 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-20-2021 18:40:04 (UTC+03:00) Istanbul this page is not applicale for this subject due to
pragnency of subject.unblinding did not applicable
for this subject.
Not Applicable
1Jan-20-2021 17:20:03 (UTC+03:00) Istanbul
1Jan-15-2021 15:12:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822041
Page 112 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sila Akhan Approved Jan-21-2021 13:29:41 (UTC+03:00) Istanbul BOOK 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 Jan-20-2021 17:19:19 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Jan-20-2021 15:29:22 (UTC+03:00) Istanbul BOOK 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 Jan-19-2021 15:55:09 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Jan-18-2021 14:41:26 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822042
Page 113 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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-15-2021 15:10:21 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Jan-04-2021 14:52:01 (UTC+03:00) Istanbul BOOK 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.
Binnur Yildirim N/A Jan-03-2021 17:35:03 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Dec-23-2020 12:20:45 (UTC+03:00) Istanbul BOOK 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.
Binnur Yildirim N/A Dec-22-2020 16:49:49 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822043
Page 114 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
N/A
Sila Akhan Approved Dec-18-2020 15:31:28 (UTC+03:00) Istanbul BOOK 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.
Binnur Yildirim N/A Dec-18-2020 15:03:20 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Dec-17-2020 13:43:58 (UTC+03:00) Istanbul BOOK 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.
Binnur Yildirim N/A Dec-16-2020 16:47:43 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Dec-15-2020 13:30:28 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822044
Page 115 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.
Binnur Yildirim N/A Dec-15-2020 10:55:23 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Dec-15-2020 08:33:18 (UTC+03:00) Istanbul BOOK 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 Dec-09-2020 19:56:53 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Dec-09-2020 16:20:57 (UTC+03:00) Istanbul BOOK 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.
Binnur Yildirim N/A Dec-07-2020 16:42:16 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822045
Page 116 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
N/A
Sila Akhan Approved Dec-02-2020 20:54:20 (UTC+03:00) Istanbul BOOK 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 Nov-19-2020 15:23:11 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan Approved Nov-04-2020 11:24:36 (UTC+03:00) Istanbul BOOK 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.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822046
Page 117 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-30-2020 11:30:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-30-2020 11:30:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822047
Page 118 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-30-2020 11:30:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
OBTAINED
Date Written Consent Obtained
Oct/30/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822048
Page 119 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-30-2020 11:29:58
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12171031Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 11:29:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020 11:30:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-30-2020 11:30:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-30-2020 11:30:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
WHITEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822049
Page 120 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 19:47:47
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 19:47:30
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Oct-30-2020 15:03:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-03-2020 19:47:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Transcription Error
Nov-03-2020 19:47:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822050
Page 121 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-30-2020 15:04:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 15:04:22
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 15:04:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822051
Page 122 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-30-2020 15:43:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822052
Page 123 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
65.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
155.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.1Initial Entry
7.a
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822053
Page 124 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020 15:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822054
Page 125 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822055
Page 126 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-30-2020 15:45:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822056
Page 127 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-30-2020 15:45:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020 15:45:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
114923Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822057
Page 128 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 15:04:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 15:04:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 15:05:06
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 15:04:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-30-2020 15:04:53
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 15:05:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ96WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 15:05:06 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822058
Page 129 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul BPZ96W
5.b
Date Location User Value Reason
Oct-30-2020 15:05:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ96XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 15:05:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZ96XInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020 15:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BS2S3VInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020 15:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BS2S3VInitial Entry
5.d
Date Location User Value Reason
Nov-19-2020 15:23:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BS2S3WInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-19-2020 15:23:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BS2S3WInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822059
Page 130 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 15:07:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 15:07:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 15:07:35
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 15:07:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-30-2020 15:07:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 15:07:35
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ96HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 15:07:35 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822060
Page 131 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul BPZ96H
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822061
Page 132 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/30/2020 11:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822062
Page 133 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-30-2020 15:46:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822063
Page 134 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-30-2020 15:46:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822064
Page 135 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020 14:26:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-23-2020 14:27:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Answered updated
Nov-23-2020 13:50:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to update
missing SWAB PFE
and VACIN TRT
form or else clarify.
Thank you.
Nov-19-2020 15:26:21
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0822065
Page 136 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822066
Page 137 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NO
2.b Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822067
Page 138 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822068
Page 139 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822069
Page 140 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822070
Page 141 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-19-2020 15:35:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DNInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822071
Page 142 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822072
Page 143 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 15:34:47
(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-19-2020 15:34:47
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822073
Page 144 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822074
Page 145 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-19-2020 15:31:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822075
Page 146 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822076
Page 147 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-19-2020 15:26:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822077
Page 148 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 14:24:23
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 14:24:23
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 14:24:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 14:24:23
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-23-2020 14:24:23
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 14:24:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ9GXInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 14:24:39 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822078
Page 149 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul BPZ9GX
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822079
Page 150 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-23-2020 14:25:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Nov/19/2020
Reason(s) for Temporary Delay of
Vaccination
RECENT NON-STUDY VACCI
NATIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020 11:03:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-18-2020 11:02:09
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened DM: Please let us
know planned
vaccination 2 date or
else clarify on recent
subject status. Thank
you.
Nov-25-2020 14:41:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Candidate to follow up delay
Nov-24-2020 14:44:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-24-2020 14:40:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-24-2020 14:43:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822080
Page 151 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
administration?
Date Location User Value Reason
Nov-24-2020 14:44:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822081
Page 152 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 13:37:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822082
Page 153 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 09:37:33
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed As per site
confirmation -
updated PD tracker
Dec-18-2020 14:58:21
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 1: Answered the visit 2 was done,
but vaccination 2 did
not give. so second
'Vaccination
Symptoms Diary-
Symptom Resolved
Dates' is not
applicable for
subject.
Dec-18-2020 11:56:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened PDQ: Vaccination is
given, however
FORM level
comment added as
NOT Applicable
added on
‘Vaccination
Symptoms Diary-
Symptom Resolved
Dates’ CRF. Please
review and update
else clarify.
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822083
Page 154 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
09:24:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 Bhumika Prabhu Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:36:34
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491346;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.b
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822084
Page 155 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
07:33:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:36:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491347;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.c
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822085
Page 156 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:36:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491348;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.d
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822086
Page 157 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.d Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:37:43
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491349;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.e
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822087
Page 158 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.e Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:37:25
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491350;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.f
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822088
Page 159 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:37:09
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491351;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.g
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822089
Page 160 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
09:23:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:36:19
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491352;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2.h
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: Not
Appli
cable
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822090
Page 161 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Dec-19-2020
19:38:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:18:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6491353;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822091
Page 162 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not
Appli
cableInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020
11:05:33
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clos
edResponse satisfies query
Dec-19-2020
19:35:25
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:22:47
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6491355;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Dec-17-2020
13:37:36ACV0PFEINFP6000 Data
Entry:Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822092
Page 163 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulNot A
pplica
ble
5.b
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822093
Page 164 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clos
edResponse satisfies query
Dec-19-2020
19:35:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:22:47
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6491356;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry:
Not A
pplica
bleInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:Not
Appli
cableInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822094
Page 165 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 13:37:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020
12:08:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clos
edResponse satisfies query
Dec-19-2020
19:35:02
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredThe second vaccination
did not administrated to
the subject. so there is no
second vaccination
questionary.
Dec-18-2020
20:22:47
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6491357;Reactions
Occur? is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Dec-17-2020
13:37:36
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry:
Not A
pplica
bleInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822095
Page 166 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 13:37:58
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 13:37:58
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 13:38:19
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 13:37:58
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Dec-17-2020 13:37:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 13:38:19
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ9CVInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 13:38:19 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822096
Page 167 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul BPZ9CV
5.b
Date Location User Value Reason
Dec-17-2020 13:38:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BPZ9CWInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 13:38:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BPZ9CWInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 13:38:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BNLZT7Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 13:38:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BNLZT7Initial Entry
5.d
Date Location User Value Reason
Dec-17-2020 13:38:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BNLZT8Initial Entry
5.d Sample ID
Date Location User Value Reason
Dec-17-2020 13:38:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BNLZT8Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822097
Page 168 of 201
***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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimForm Created
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822098
Page 169 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-07-2020 16:42:16
(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
Dec-17-2020 13:19:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-11-2020 15:55:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 2: Answered The termination name will be
updated and sent today with
new SAE follow up report
Dec-11-2020 14:42:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020484307,ter,
updated to Exposure during
pregnancy in AE CRF. Please
confirm if a follow up AEM
form was submitted to update
term in Safety database.
Dec-11-2020 11:48:18
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies query
Dec-09-2020 20:50:56
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-09-2020 20:50:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
exposure during pregnancyNew Information
Dec-09-2020 16:07:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened clinical query: as per CRF
guideline section 8.50.2.5 a
healthy Pregnancy is not an AE
term that is required to be on
the CRF please change into
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822099
Page 170 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
exposure during pregnancy.
Thanks
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-04-2021 12:50:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 4: Closed Onset date matched in
both DB
Jan-03-2021 17:35:03
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered The date of start date
was updated
according to the SAE
follow up-6.
Jan-03-2021 17:35:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
Oct/30/2020 11:55The date of start date
was updated
according to the SAE
follow up-6.
Dec-31-2020 12:00:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 4: Reissued:Opened SAE RECON: Per
narrative,the date of
Last menstrual period
is 26Oct2020. Based
on CRG specific
guidelines for
pregnancy this is the
correct onset
date.LMP could be
used as date of
conception if
ultrasound results are
not available.Please
update accordinly
Dec-22-2020 16:09:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 4: Reissued:Candidate Pending SDB update
Dec-19-2020 20:12:59
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 4: Answered SAE follow up form
will be update as soon
as possible
Dec-18-2020 15:54:29
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 4: Opened SAE RECON:
AER#2020484307,
onset date was
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822100
Page 171 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
recorded as
02Nov2020 in Safety
database while
26OCT2020 in AE
CRF. Please submit a
follow up AEM form
to update onset date in
Safety database.
Dec-17-2020 07:32:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-16-2020 16:47:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 3: Answered AE date was updated
according to DM
request;CCG page184
"In the absence of
ultrasound, the data
from the last
menstrual period
(LMP) should be used
to estimate date of
conception".So the
AE date updated
according to LMP.
Dec-16-2020 12:31:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Reissued:Opened DM: Thank you for
response. Kindly refer
CCG section
‘8.50.2.5. Specific
Guidance for
Pregnancy’ for ‘Date
of Onset’ part and
update AE start date if
needed per CCG. Else
clarify.
Dec-15-2020 07:50:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-14-2020 19:59:23
(UTC+03:00) IstanbulACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response satisfies
query
Dec-14-2020 14:05:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Answered This date is last
menstrual
period(LMP) all fast
pregnancy test , test
result were negative
before consent date
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822101
Page 172 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(V1D1VX1L).
Dec-14-2020 14:05:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Answered This date is last
menstrual
period(LMP) all fast
pregnancy test , test
result were negative
before consent date
(V1D1VX1L).
Dec-14-2020 13:59:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For exposure during
pregnancy: Start date
26/Oct/2020 is before
V1D1VX1L visit date
30/Oct/2020. Please
review and update as
appropriate.
Dec-14-2020 13:59:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Start date is before
Consent Date 30/Oct
/2020.
Dec-14-2020 13:59:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Dec-14-2020 13:59:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Oct/26/2020 UNK:UNKChanged Information
Dec-14-2020 05:05:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Giselle Castillo Query 1: Reissued:Opened Thank you for your
response. Per CRF
CG 8.50.2.5, the date
of Last menstrual
period (LMP) could
be used as the onset
date for the AE of
Exposure during
pregnancy in the
absence of ultrasound
report. Kindly revise
form. Thank you.
Dec-12-2020 23:22:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 1: Answered sstart date will be
updated when
ultrasound report is
available
Dec-11-2020 16:56:52
(UTC+03:00) IstanbulACV0PFEINFP6000 Giselle Castillo Query 1: Opened Per SAE report, the
LMP was 26Oct2020.
Based on CRF CG
(section 8.50.2.5),
when the pregnancy
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822102
Page 173 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
occurred after Vax1,
the onset date should
be determined by
ultrasound or LMP.
Please revise and
update accordingly.
Thank you.
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
Nov/UNK/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-11-2020 11:47:36
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-09-2020 19:58:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Dec-09-2020 19:56:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Dec-09-2020 19:56:53
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Transcription Error
Dec-09-2020 16:09:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened clinical query: as per
eCRF guideline
toxicity grade is not
applicable
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
4Initial 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
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822103
Page 174 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-31-2020 12:01:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 6: Closed Response satisfies query
Dec-22-2020 16:49:49
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 6: Answered Changed Information
Dec-22-2020 16:49:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOChanged Information
Dec-22-2020 16:11:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 6: Reissued:Opened SAE RECON 1: seriousness
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1.. Please downgrade
seriousness to No
Dec-18-2020 18:15:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 6: Answered these "EXPOSURE DURING
PREGNANCY" has already
submitted as SAE to Pfizer
acccording to the protocol and
the SAE number is
"2020484307".could you please
help how should these section
will be update?
Dec-17-2020 16:29:33
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 6: Opened SAE RECON:
AER#2020484307,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Dec-17-2020 16:28:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 5: Deleted Query can be addressed
internally
Dec-14-2020 22:27:06
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YES
Is this serious event asso
ciated with congenital anTranscription Error
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822104
Page 175 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt serious event
YES
Dec-14-2020 16:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE exposure during
pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Dec-14-2020 16:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
YES
Did this serious event res
ult in death?The AE "exposure during
pregnancy" has already
submitted as SAE to sponsor.
This is a SAE per protocol due
to Subject is pregnant. This is an
important medical event,
however subject does not meet
other options.
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0822105
Page 176 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt serious event
YES
Dec-11-2020 14:36:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Closed Response satisfies query
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822106
Page 177 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-09-2020 20:53:19
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Dec-09-2020 20:53:19
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Dec-09-2020 20:53:19
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOTranscription Error
Dec-09-2020 20:50:56
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE exposure during
pregnancy: Response to "Is
the adverse event serious?" is
'Yes' but "Serious Adverse
Event Number" is blank.
Dec-09-2020 16:39:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Opened SAE RECON:
AER#2020484307,pregnancy
event was appropriately
reported to safety; however,
seriousness criteria is met
there is an abnormal
pregnancy outcome/protocol
section 8.3.5.1. Please update
seriousness criteria
accordingly.
Dec-09-2020 16:34:28
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies query
Dec-09-2020 11:19:29
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-08-2020 16:46:40
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 1: Answered serious adverse number
:2020484307. ı can not enter
this number on the page.
Dec-08-2020 12:56:10
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened For AE pregnancy: Response
to "Is the adverse event
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822107
Page 178 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
serious?" is 'Yes' but "Serious
Adverse Event Number" is
blank.
Dec-08-2020 09:37:40
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto Query
Dec-08-2020 09:37:40
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
YESthe subject is pregnant. so
this event is serious.
Dec-08-2020 07:36:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Reissued:Opened Response does not satisfy
query. Response to several
Seriousness criteria' are still
missing. If Serious is YES,
then response to all
Seriousness Criteria' should
be selected NO or YES as
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822108
Page 179 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
appropriate. Please update.
Dec-07-2020 22:23:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 2: Answered updated
Dec-07-2020 16:42:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YES
Other medically important
serious event
YESTranscription Error
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse event serious?'
is reported 'Yes', but at least
one seriousness criteria is
missing. Please review and
update as appropriate.
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE pregnancy: Response
to "Is the adverse event
serious?" is 'Yes' but "Serious
Adverse Event Number" is
blank.
Dec-07-2020 16:42:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YESInitial 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
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822109
Page 180 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
subject pregnant
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021
10:13:28
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1:
ClosedResponse satisfies
query
Jan-15-2021
13:39:51
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1:
AnsweredVolunteer will not
be able to take
study drug because
she is pregnant
Jan-15-2021
07:47:36
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1:
OpenedDMW6842220;The
Latest Action to
Study Treatment is
DRUG
WITHDRAWN,
but the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Dec-14-2020
22:31:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Data Ent
ry:
DRUG W
ITHDRA
WNTranscription Error
Dec-07-2020
22:23:04
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Data Ent
ry:
NOT APP
LICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822110
Page 181 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020 12:27:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-18-2020 15:50:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-18-2020 15:04:22
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 4: Answered data was change
according to the 'the
latest EDP guidance,
outcome should be
recorded as
UNKNOWN'.
Dec-18-2020 15:03:20
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Dec-18-2020 15:03:20
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered data updated
according to the 'the
latest EDP guidance,
outcome should be
recorded as
UNKNOWN'.
Dec-18-2020 15:03:20
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
UNKNOWNdata updated
according to the 'the
latest EDP guidance,
outcome should be
recorded as
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822111
Page 182 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
UNKNOWN'.
Dec-17-2020 16:32:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 3: Opened SAE RECON:
AER#2020484307,
the outcome in AE
CRF was reported as
NOT
RECOVERED/NOT
RESOLVED.Based on
the latest EDP
guidance, outcome
should be recorded as
UNKNOWN. Please
confirm and update
accordingly.
Dec-11-2020 16:08:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOT RECOVERED/NOT RES
OLVEDChanged Information
Dec-11-2020 11:47:02
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-11-2020 07:44:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-09-2020 20:56:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 2: Answered the adverse event still
ongoing
Dec-09-2020 20:54:25
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Dec-09-2020 20:54:25
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Dec-09-2020 20:54:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
UNKNOWNChanged Information
Dec-09-2020 16:11:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened clinical query: as per
eCRF guideline AE
outcome for ongoing
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822112
Page 183 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
pregnancy should be
unknonwn. Please
check and update the
eCRF if needed.
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-15-2020 14:44:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Dec-15-2020 11:00:04
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered subject's treatment is
stopped, but she will
come to the follow
up visits
Dec-15-2020 11:00:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
NOsubject's treatment is
stopped, but she will
come to the follow
up visits
Dec-15-2020 00:26:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Thank
you for confirming
treatment was
discontinued. Will
the subject continue
to participate in
follow up visits? If
so, please review
response to this field
Dec-14-2020 22:33:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimQuery 1: Answered Line #9 was
updated.Subject was
discontinued on the
Impala due to
pregnancy.
Dec-14-2020 21:03:53
(UTC+03:00) IstanbulACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Field
indicates subject will
no longer participate
in study follow up.
Meanwhile question
10 'Last Action
Taken with Study
Drug' reports no
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822113
Page 184 of 201
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
change (Not
applicable). Please
review if questions
have been answered
correctly
Dec-07-2020 22:23:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
YESInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822114
Page 185 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-24-2020 18:06:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822115
Page 186 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-24-2020 18:07:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822116
Page 187 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 18:06:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 18:06:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 18:06:48
(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).
Date Location User Value Reason
Nov-24-2020 18:06:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Hepatitis A VaccinationInitial Entry
5. Date:
Date Location User Value Reason
Nov-24-2020 18:06:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822117
Page 188 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 18:07:15
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 18:07:15
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 18:07:15
(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).
Date Location User Value Reason
Nov-24-2020 18:07:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Hepatitis B VaccinationInitial Entry
5. Date:
Date Location User Value Reason
Nov-24-2020 18:07:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822118
Page 189 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 12:19:09
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822119
Page 190 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: UNPLANNED VISIT - 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Nov-03-2020 12:19:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 12:19:17
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Nov-03-2020 12:19:17
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822120
Page 191 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/03/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Nov-03-2020 12:19:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Nov-03-2020 12:19:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Nov/3/2020
Contact Outcome:
VISIT NOT REQUIRED, INVES
TIGATOR DECISIONInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822121
Page 192 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-07-2020 22:24:19
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
Dec/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-07-2020 22:24:19
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-15-2020
14:39:19
(UTC+03:00)
IstanbulACV0PFEINFP6000 Hayley Wyper Query
3: Clos
edResponse satisfies query
Dec-15-2020
10:56:07
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
4: Clos
edClose Auto Query
Dec-15-2020
10:55:23
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
4: Ope
nedResponse to "Status" is
PREGNANCY but
"Specify Status" is
Provided.
Dec-15-2020
10:55:23
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredChanged Information
Dec-15-2020
10:55:23
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Data
Entry:
PREG
NANC
YChanged Information
Dec-14-2020
22:34:30
(UTC+03:00)ACV0PFEINFP6000 Query
3: Ope
nedCLINQUERY: per AE
log and Specify status
field, study treatment
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822122
Page 193 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul was ceased due to
pregnancy. Please
capture PREGNANCY
as status selection for
EOT
Dec-14-2020
20:58:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Hayley Wyper Query
3: Can
didateCLINQUERY: per AE
log and Specify status
field, study treatment
was ceased due to
pregnancy. Please
capture PREGNANCY
as status selection for
EOT
Dec-12-2020
23:29:58
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
2: Clos
edClose Auto Query
Dec-12-2020
23:29:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query
2: Ope
nedResponse to "Status" is
NO LONGER MEETS
ELIGIBILITY
CRITERIA but "Specify
Status" is missing.
Dec-12-2020
23:29:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Dele
tedChanged Information
Dec-12-2020
23:29:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Data
Entry:
NO L
ONGE
R ME
ETS E
LIGIB
ILITY
CRITE
RIAChanged Information
Dec-11-2020
11:54:15
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Reis
sued:C
andidat
eIssue added in DM
Meeting and Q & A
sheet.
Dec-09-2020
11:16:38ACV0PFEINFP6000 Query
1: AnsThis is not schedule
visit.However unplan
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822123
Page 194 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbulwered page should be
completed for only
REACTOGENICITY
contacts per
protocol.eCRF
manuel:“Unscheduled
Visit for a Grade 3 or
Suspected Grade 4
Reaction for Stage 3
Cohorts section".So
these local lab result can
not ent
Dec-09-2020
09:46:51
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Reis
sued:O
penedPlease confirm if
'positive beta HCG test
on 07dec2020 in local
laboratory' occurred as a
scheduled visit? or an
unplanned visit? and
update applicable visit
and CRFs accordingly.
Dec-08-2020
16:47:57
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Query
1: Ans
weredsubject has a positive
beta HCG test on
07dec2020 in local
laboratory. could you
please inform me where
can I enter this result in
the eCRF
Dec-08-2020
09:57:08
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6380622;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Dec-07-2020
22:24:19
(UTC+03:00)
IstanbulACV0PFEINFP6000 Binnur Yildirim Data
Entry:
PREG
NANC
YInitial Entry
4. Specify Status:
Date Location User Value Reason
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822124
Page 195 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-15-2020 10:56:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry: Transcription Error
Dec-15-2020 10:56:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
tTranscription Error
Dec-12-2020 23:29:58
(UTC+03:00) IstanbulACV0PFEINFP6000 Binnur
YildirimData Entry:
Meet Excl 11. Subject is pregnantInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822125
Page 196 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-20-2021 18:51:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 18:48:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 18:38:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 17:19:19
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Transcription Error
Jan-19-2021 16:31:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-19-2021 15:55:09
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-19-2021 15:55:09
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/30/2020Transcription Error
Jan-19-2021 09:01:13
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened DM: The response
for "Date Treatment
Unblinded" is
missing. Kindly
review and update.
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021 18:51:04
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 18:48:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 18:38:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 17:19:19 ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0822126
Page 197 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul
Jan-15-2021 15:10:21
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae2f27\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822127
Page 198 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-20-2021 18:51:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 18:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Initial Entry
Jan-20-2021 18:39:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 18:39:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry: Transcription Error
Jan-15-2021
…[truncated]