125742 S1 M5 CRF c4591001 1207 12071055

Document text

Page 1 of 166
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820895
Page 2 of 166
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/5/2020
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820896
Page 3 of 166
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12071055]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820897
Page 4 of 166
***Confidential***
 
Header Text  C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820898
Page 5 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820899
Page 6 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820900
Page 7 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[heart stent replacement surgery]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[secong degree liver cirhosis]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820901
Page 8 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820902
Page 9 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
2.Weight: [84.9]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820903
Page 10 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/5/2020
2.Randomization Number: [274049]
3.Randomization Group: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820904
Page 11 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BRDGSR]
5.bSample ID [BRDGSS]
5.cSample ID [BSHZN9]
5.dSample ID [BSHZNB]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820905
Page 12 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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/5/2020
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 [BRDGR7]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820906
Page 13 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/5/2020 10:22
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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820907
Page 14 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820908
Page 15 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/26/2020
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820909
Page 16 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820910
Page 17 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820911
Page 18 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820912
Page 19 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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/26/2020
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 [BRDGVN]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820913
Page 20 of 166
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/26/2020 10:54
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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820914
Page 21 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820915
Page 22 of 166
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820916
Page 23 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820917
Page 24 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5P01]
5.bSample ID [BR5P02]
5.cSample ID [BSHZWN]
5.dSample ID [BSHZWP]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820918
Page 25 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820919
Page 26 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820920
Page 27 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820921
Page 28 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820922
Page 29 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820923
Page 30 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820924
Page 31 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820925
Page 32 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820926
Page 33 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820927
Page 34 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820928
Page 35 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820929
Page 36 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820930
Page 37 of 166
***Confidential***
 
Header Text  C4591001
Visit: POT_COVID_CONVA - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820931
Page 38 of 166
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820932
Page 39 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820933
Page 40 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820934
Page 41 of 166
***Confidential***
 
Header Text  C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identifie
rAdverse Event Start DateIs the Adverse Event Still Ongoi
ngForm Instance
 1.ADVERSE EVEN
T 1  Bacterial Pneumoni
a Feb/5/2021 UNK:UN
K NO
End Date Time:
Feb/9/2021 UNK:UNK
 Repeating Pages
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820935
Page 42 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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)[Bacterial Pneumonia]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/9/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[bacterial]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820936
Page 43 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13.What was the outcome of this adverse
event?:FATAL
14.Did the adverse event cause the subject
to be discontinued from the study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021139362]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820937
Page 44 of 166
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
 1.          Repeating Pages
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820938
Page 45 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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[ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820939
Page 46 of 166
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820940
Page 47 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820941
Page 48 of 166
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820942
Page 49 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820943
Page 50 of 166
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820944
Page 51 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820945
Page 52 of 166
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820946
Page 53 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820947
Page 54 of 166
***Confidential***
 
Header Text  C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820948
Page 55 of 166
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820949
Page 56 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820950
Page 57 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820951
Page 58 of 166
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820952
Page 59 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820953
Page 60 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820954
Page 61 of 166
***Confidential***
 
Header Text  C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820955
Page 62 of 166
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820956
Page 63 of 166
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820957
Page 64 of 166
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820958
Page 65 of 166
***Confidential***
 
Header Text  C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820959
Page 66 of 166
***Confidential***
 
Header Text  C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820960
Page 67 of 166
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo at
Vaccination 1/2
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820961
Page 68 of 166
***Confidential***
 
Header Text  C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Feb/9/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820962
Page 69 of 166
***Confidential***
 
Header Text  C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820963
Page 70 of 166
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820964
Page 71 of 166
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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:Feb/11/2021 Comments
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Bacterial pneumonia]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820965
Page 72 of 166
***Confidential***
 
Header Text  C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820966
Page 73 of 166
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Done Comments
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820967
Page 74 of 166
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820968
Page 75 of 166
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: DEATH
4.Specify Status: [visit did not occur because of subject death. this page needs to be complete.]
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820969
Page 76 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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 Feb/9/2021
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820970
Page 77 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820971
Page 78 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Ismail Balik  Approved Mar-10-2021 10:28:06 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820972
Page 79 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-05-2020 14:39:24 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820973
Page 80 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-18-2021 16:28:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820974
Page 81 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-18-2021 16:28:35 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820975
Page 82 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-15-2021 10:23:34 (UTC+03:00) Istanbul
FormJan-18-2021 16:28:53 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820976
Page 83 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-15-2021 10:23:34 (UTC+03:00) Istanbul
1Jan-18-2021 16:28:53 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820977
Page 84 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-09-2021 14:04:16 (UTC+03:00) Istanbul Not Done
FormMar-09-2021 14:02:22 (UTC+03:00) Istanbul
FormFeb-11-2021 12:26:54 (UTC+03:00) Istanbul Not Done
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820978
Page 85 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-09-2021 14:04:16 (UTC+03:00) Istanbul Not Done
1Mar-09-2021 14:02:22 (UTC+03:00) Istanbul
1Feb-11-2021 12:26:54 (UTC+03:00) Istanbul Not Done
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820979
Page 86 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-09-2021 14:04:16 (UTC+03:00) Istanbul Not Done
2Mar-09-2021 14:02:22 (UTC+03:00) Istanbul
2Feb-11-2021 12:26:54 (UTC+03:00) Istanbul Not Done
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820980
Page 87 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-11-2021 12:27:16 (UTC+03:00) Istanbul Not Done
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820981
Page 88 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-11-2021 12:27:16 (UTC+03:00) Istanbul Not Done
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820982
Page 89 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-11-2021 12:27:37 (UTC+03:00) Istanbul Not Applicable
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820983
Page 90 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Ismail Balik  Approved Mar-10-2021 10:28:06 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-09-2021 14:02:22 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-22-2021 14:23:24 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-22-2021 13:40:58 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-19-2021 10:49:19 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820984
Page 91 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Feb-19-2021 10:22:01 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-18-2021 12:39:47 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-18-2021 11:22:33 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-17-2021 12:38:22 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-17-2021 12:34:10 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-17-2021 10:33:21 (UTC+03:00) Istanbul BOOK Signed
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820985
Page 92 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-17-2021 10:23:05 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-15-2021 14:34:45 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-15-2021 14:17:51 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-15-2021 11:50:13 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
  N/A Feb-12-2021 19:38:23 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820986
Page 93 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ismail Balik  Approved Feb-12-2021 12:45:28 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-11-2021 11:52:52 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-10-2021 15:19:06 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-10-2021 14:19:37 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Feb-09-2021 15:37:02 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-09-2021 13:49:24 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820987
Page 94 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
N/A
Ismail Balik  Approved Jan-19-2021 15:29:24 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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-18-2021 16:26:53 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Jan-15-2021 09:56:17 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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 09:51:20 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Jan-12-2021 15:29:27 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820988
Page 95 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Jan-12-2021 11:38:14 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Dec-01-2020 10:07:08 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-26-2020 11:57:39 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Ismail Balik  Approved Nov-17-2020 20:32:15 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, IsmailBalik, 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.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820989
Page 96 of 166
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-05-2020 12:57:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-05-2020 12:57:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820990
Page 97 of 166
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-05-2020 14:37:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/5/2020Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820991
Page 98 of 166
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-05-2020 12:57:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12071055Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-05-2020 12:57:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-05-2020 14:38:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-05-2020 14:38:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-05-2020 14:38:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820992
Page 99 of 166
***Confidential***
 
Header Text  C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 14:39:08
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820993
Page 100 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-05-2020 14:39:45
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 14:39:45
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020 14:39:45
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820994
Page 101 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-05-2020 14:40:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:type 2 diabetes
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-05-2020 14:40:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 14:40:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-05-2020 14:40:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-05-2020 14:40:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-05-2020 14:41:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:heart stent replacement
surgery
Start Date: UNK/UNK/2005Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820995
Page 102 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ongoing: NO
End Date:
UNK/UNK/2005
1.b Line/MH Number:
Date Location User Value Reason
Nov-05-2020 14:41:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 14:41:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
heart stent replacement surgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-05-2020 14:41:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-05-2020 14:41:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.c
Date Location User Value Reason
Nov-05-2020 22:23:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:3
Medical History
Term:secong degree liver
cirhosis
Start Date: UNK/UNK/2015
Ongoing: YESTranscription Error
Nov-05-2020 14:43:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:secong degree cir
hosis
Start Date: UNK/UNK/2015Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820996
Page 103 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ongoing: YES
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820997
Page 104 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Nov-05-2020 14:43:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020
05:34:47
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Closed Discrepancy has
been closed.
Nov-05-2020
22:23:51
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Nov-05-2020
22:23:51
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
secong degree liver c
irhosisTranscription
Error
Nov-05-2020
16:43:40
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Opened Clarify SECONG
DEGREE
CIRHOSIS as
follows...The term
appears
incomplete. Are
you reporting
LIVER
CIRRHOSIS?
BILIARY
CIRRHOSIS?
CARDIAC
CIRRHOSIS?
Other? Please
update the
verbatim term to
clarify. Thank
you.
Nov-05-2020
14:43:54
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
secong degree cirhosi
sInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-05-2020 14:43:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0820998
Page 105 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Ongoing:
Date Location User Value Reason
Nov-05-2020 14:43:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0820999
Page 106 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-05-2020 14:44:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821000
Page 107 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
84.9Initial Entry
3. Unit:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821001
Page 108 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a Record Identifier:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-05-2020 14:44:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821002
Page 109 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-05-2020 14:47:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-05-2020 14:47:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
274049Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821003
Page 110 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 14:47:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 14:47:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 15:45:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 14:47:43
(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-05-2020 14:47:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 15:45:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDGSRInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 15:45:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDGSRInitial Entry
5.b
Date Location User Value Reason
Nov-05-2020 15:46:02 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821004
Page 111 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul Sample ID: BRDGSS
5.b Sample ID
Date Location User Value Reason
Nov-05-2020 15:46:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDGSSInitial Entry
5.c
Date Location User Value Reason
Jan-12-2021 11:38:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHZN9Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-12-2021 11:38:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHZN9Initial Entry
5.d
Date Location User Value Reason
Jan-12-2021 11:38:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHZNBInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-12-2021 11:38:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHZNBInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821005
Page 112 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 14:48:02
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 14:48:02
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 15:46:18
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 14:48:02
(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-05-2020 14:48:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 15:46:18
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDGR7Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 15:46:18
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDGR7Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821006
Page 113 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/5/2020 10:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821007
Page 114 of 166
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-05-2020 14:48:29
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821008
Page 115 of 166
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-05-2020 14:48:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821009
Page 116 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-26-2020 11:57:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/26/2020Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821010
Page 117 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821011
Page 118 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821012
Page 119 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.d Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821013
Page 120 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAINInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821014
Page 121 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.h Symptom:
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821015
Page 122 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821016
Page 123 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-26-2020 12:00:50
(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-26-2020 12:00:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821017
Page 124 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/26/2020Initial Entry
2.a
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-26-2020 12:01:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821018
Page 125 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-26-2020 12:01:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-26-2020 12:01:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-26-2020 12:02:24
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-26-2020 12:01:58
(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.
Nov-26-2020 12:01:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/26/2020Initial Entry
5.a
Date Location User Value Reason
Nov-26-2020 12:02:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDGVNInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-26-2020 12:02:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDGVNInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821019
Page 126 of 166
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/26/2020 10:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821020
Page 127 of 166
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-26-2020 12:51:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821021
Page 128 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021
08:30:30
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2:
ClosedResponse satisfies query
Jan-19-2021
12:48:04
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2:
AnsweredChanged data per query
Jan-19-2021
12:40:41
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2:
OpenedDM: The treatment period is
defined as 1st vaccination visit
through the 1-month post
vaccination visit after the 2nd
vaccination. Please complete
treatment disposition CRF and
update date of EOT to match
date of visit at visit 3.
Jan-19-2021
10:30:43
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1:
ClosedPer site confirmation_Updated
PD tracker
Jan-18-2021
09:17:48
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 1:
AnsweredOriginal value is correct
Jan-18-2021
08:57:39
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 14 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Jan-15-2021
09:51:20
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Ent
ry:
Jan/14/20
21Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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)
(b) (4)
FDA-CBER-2021-5683-0821022
Page 129 of 166
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821023
Page 130 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821024
Page 131 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.d Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821025
Page 132 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAINInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821026
Page 133 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.h Symptom:
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821027
Page 134 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821028
Page 135 of 166
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-15-2021 09:52:38
(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
Jan-15-2021 09:52:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821029
Page 136 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 09:52:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 09:52:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 09:53:21
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 09:52:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-15-2021 09:52:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-15-2021 09:53:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BR5P01Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 09:53:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5P01Initial Entry
5.b
Date Location User Value Reason
Jan-15-2021 09:53:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821030
Page 137 of 166
***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: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul Sample ID: BR5P02
5.b Sample ID
Date Location User Value Reason
Jan-15-2021 09:53:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BR5P02Initial Entry
5.c
Date Location User Value Reason
Jan-15-2021 09:53:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHZWNInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-15-2021 09:53:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHZWNInitial Entry
5.d
Date Location User Value Reason
Jan-15-2021 09:54:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHZWPInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-15-2021 09:54:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHZWPInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821031
Page 138 of 166
***Confidential***
 
Header Text  C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821032
Page 139 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021 13:49:24
(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
Mar-03-2021
15:36:39
(UTC+03:00)
IstanbulACV0PFEINFP6000  Giselle Castillo Query 2: Closed Thanks for
confirming.
Clinical will
continue to FU at a
later date.
Feb-25-2021
10:26:46
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Answered participant family
could not receive
the medical records
to the site yet
Feb-25-2021
00:01:47
(UTC+03:00)
IstanbulACV0PFEINFP6000  Giselle Castillo Query 2: Reissued:O
penedThanks for your
response, would
you provide
updates so I can
close the query?
Feb-18-2021
10:50:32
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 2: Answered medical records are
not available right
now. Clarification
will be done when
information
obtained.
Feb-17-2021
22:12:26
(UTC+03:00)
IstanbulACV0PFEINFP6000  Giselle Castillo Query 2: Opened Medical Monitor_
Pls provide further
information on
hospital stay. Could
you provide
updates on Med
records? Thanks
Feb-09-2021
17:14:39
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Closed Discrepancy has
been closed.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821033
Page 140 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021
15:19:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-09-2021
15:19:57
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Bacterial PneumoniaTranscription Error
Feb-09-2021
15:15:03
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Opened Clarify
BACTERIAL
PNEUMONI as
follows...The term
appears truncated.
Are you reporting
BACTERIAL
PNEUMONIA? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
term. Thank you.
Feb-09-2021
13:49:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
Bacterial PneumoniInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/5/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-17-2021 12:51:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-17-2021 12:34:38
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-17-2021 12:34:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/9/2021 UNK:UNKTranscription Error
Feb-17-2021 12:09:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened please update the date,
subject death date
09Feb21
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821034
Page 141 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-11-2021 12:32:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-11-2021 12:32:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKNew Information
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition Follow-up
form is completed and
this Adverse Event is
still ongoing. Please
review and update as
appropriate.
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data 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
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
Feb-18-2021 07:46:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 3: Closed Response satisfies query
Feb-17-2021 12:50:04
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 5: Closed Response satisfies query
Feb-17-2021 12:49:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 4: Closed Response satisfies query
Feb-17-2021 12:34:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered Transcription Error
Feb-17-2021 12:34:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Transcription Error
Feb-17-2021 12:34:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?Transcription Error
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821035
Page 142 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
Did this serious event result in
death?
YES
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
NO
Feb-17-2021 12:11:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 5: Opened please correct the answer for
question "Other medically
important serious event" in line
with SAE FU report, thank you
Feb-17-2021 12:10:59
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 4: Opened please correct the answer for
question "persistent or
significant
disability/incapacity" in line
with SAE FU report.
Feb-17-2021 10:23:05
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Feb-17-2021 10:23:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YESTranscription Error
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821036
Page 143 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
YES
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
YES
Feb-17-2021 08:47:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Balaji Prabu R Query 3: Opened Outcome of this AE is FATAL,
but the question "Did this
serious event result in death?"
is answered as NO. Please
verify and update as
appropriate. Else clarify.
Feb-12-2021 19:40:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed SDB updated
Feb-11-2021 12:25:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Answered SAE form was submitted to
[email protected]
on 09feb2021.
Feb-11-2021 11:57:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened SAE RECON: Bacterial
Pneumonia(Onset
date:05Feb20221) is not
reported to Safety database but
marked serious on AE CRF.
Confirm seriousness and report
to Pfizer immediately. If this
event is not serious, downgrade
the event on AE CRF
Feb-11-2021 11:56:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Deleted Query can be addressed
internally
Feb-09-2021 15:19:57
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Bacterial Pneumonia:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821037
Page 144 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Bacterial Pneumoni:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
YES
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
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
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-15-2021 21:07:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason Gong Query 1: Closed Response satisfies
query
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821038
Page 145 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-11-2021 11:48:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered according to verbal
information covid test
is negative. Result is
not shared with site.
Feb-11-2021 01:53:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason Gong Query 1: Opened GPDClin: Please
clarify if covid-19 test
was done at hospital.
If yes, what's the
result?
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
bacterialInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021 15:07:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-10-2021 14:19:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-10-2021 14:19:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOTranscription Error
Feb-10-2021 12:33:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened there is no medication
information to treat
SAE in source, please
change your answer as
"no", if you learn that
subject take
medication you can
update this part as yes
afterwards
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821039
Page 146 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Feb-17-2021
09:29:29
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
4: Clo
sedoutcome updated to Fatal in SDB
Feb-16-2021
08:20:03
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Feb-15-2021
12:20:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
4: Rei
ssued:
Candi
datePending SDB update
Feb-15-2021
10:25:16
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
3: Ans
weredChanged data per query
Feb-15-2021
10:24:44
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query
2: Del
etedAnswer Auto Query
Feb-15-2021
10:22:23
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
4: Ans
weredFU form submited on 11feb2021
Feb-12-2021
19:39:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
4: Op
enedSAE
RECON:AER#2021139362,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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)
FDA-CBER-2021-5683-0821040
Page 147 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
FATAL on AE CRF. Please confirm
correct outcome. If safety update is
required, please submit a follow-up
form.
Feb-12-2021
18:11:06
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dPlease complete the Death Details
page. The path is Visit/Form:
Disposition > DEATH DETAILS
CODED.
Feb-12-2021
11:36:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
3: Ans
weredFUP page is completed as death, is
there any page should site complete?
Feb-12-2021
07:15:18
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW7232817;The outcome of this
AE is selected as FATAL, but there
are no Disposition eCRFs with a
'Status' of DEATH. Please review
and update as appropriate.
Feb-12-2021
00:05:05
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
2: Rei
ssued:
Candi
datePlease review to see if 'Date of
Collection/Notification of Death on
the Death Details is updated by
12Feb.
Feb-11-2021
12:35:07
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
2: Ans
weredSAE form will me submitted within
today
Feb-11-2021
12:33:21
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedResponse to "What was the outcome
of this adverse event?" is 'Fatal' but
Date of Collection / Notification of
Death on the Death Details form is
not completed. Please review and
update as appropriate.
Feb-11-2021
12:33:21
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Feb-11-2021
12:33:21
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data
Entry
:
FATA
LNew Information
Feb-11-2021
12:32:55
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedFor AE Bacterial Pneumonia:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821041
Page 148 of 166
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021
13:49:24
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data
Entry
:
RECO
VERI
NG/R
ESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 15:17:44
(UTC+03:00) IstanbulACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Feb-22-2021 13:40:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-22-2021 13:40:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESTranscription Error
Feb-19-2021 20:55:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Please
review this selection
for this fatal event
occurring whilst
subject was still on
study
Feb-09-2021 13:49:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-12-2021 19:38:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2021139362Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821042
Page 149 of 166
***Confidential***
 
Header Text  C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Feb-11-2021 11:54:18
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/14/2021Transcription Error
Feb-11-2021 11:52:52
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/10/2021New Information
Jan-19-2021 12:48:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/14/2021Transcription Error
Jan-19-2021 12:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 12:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Feb-11-2021 11:54:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-11-2021 11:54:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDTranscription Error
Feb-11-2021 11:53:22
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Response to 'Status' is
'Death' on Disposition-
Folow up, but 'Death'
CRF is not yet
initiated. Please review
and update as
appropriate.
Feb-11-2021 11:53:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DEATHNew Information
Jan-19-2021 12:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821043
Page 150 of 166
***Confidential***
 
Header Text  C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021 16:26:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821044
Page 151 of 166
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021 16:28:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 16:28:02
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-18-2021 16:28:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per other protocol allowan
ce(s) and confirmed to have receiv
ed only placebo at Vaccination 1/2Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821045
Page 152 of 166
***Confidential***
 
Header Text  C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Feb-17-2021 10:25:28
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/9/2021Transcription Error
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-16-2021 00:59:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-15-2021 10:24:44
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-12-2021 18:12:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened The path is Visit/Form:
Disposition > DEATH
DETAILS CODED
Feb-12-2021 11:34:38
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered There isn't death detail
page in CRF. Could
you please add the
page to subject?
Feb-12-2021 02:13:52
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened DM RQ: Per the
CRFCR, if a
participant ends the
study due to death,
The Death Details
Coded (DEATH DTL)
CRF is required to be
completed. Currently,
the CRF is not
completed. Please
review and update
accordingly.
Feb-11-2021 12:31:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered SAE FU report will be
submitted within today
Feb-11-2021 12:31:20
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821046
Page 153 of 166
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-11-2021 12:30:49
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status" is
DEATH but "Specify
Status" is Provided.
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Response to 'Status' is
'Death' on Disposition-
Folow up, but 'Death'
CRF is not yet
initiated. Please review
and update as
appropriate.
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-11-2021 12:31:20
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 12:30:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
SAE FU report will be submitted with
in todayInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821047
Page 154 of 166
***Confidential***
 
Header Text  C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-18-2021 16:28:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-18-2021 16:28:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821048
Page 155 of 166
***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, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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-18-2021 16:28:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821049
Page 156 of 166
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-20-2021 02:20:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 3: Closed Per query responses, subject
died on 09Feb2021
(consistent with SAE
report), and site was
notified of death 11feb2021.
Date of death on FUP
(09Feb2021) and Death
details (notification of death
is 11Feb2021) appear to be
correct based on this
information.
Feb-20-2021 02:12:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed Response satisfies query
Feb-19-2021 10:26:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 3: Answered we have notified about
subject death on 11feb2021
and send to DSU team FU
report. Subject died on
09feb2021. If FUP page
must be update as
11feb2021 could you
unfreeze the page so i can
uptade it?
Feb-19-2021 10:22:01
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 09/Feb/2021. Please
review and update as
appropriate
Feb-19-2021 10:22:01
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered site was notified of death
11feb2021
Feb-19-2021 10:22:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/11/2021site was notified of death
11feb2021
Feb-19-2021 02:01:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Reissued:Opened CLINQUERY: per SAE
report, date of death was
clarified as 09Feb2021.
Please clarify if the site was
notified that day
(09Feb2021). If not, please
update "Date of Collection /
Notification of Death:" on
this death details CRF as
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821050
Page 157 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
appropriate.
Feb-19-2021 01:47:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-17-2021 10:29:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered Changed data per query
Feb-17-2021 10:26:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Answered Changed data per query
Feb-17-2021 02:36:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened CLINQUERY: please
clarify if the Death Details
Date of Collection /
Notification of Death
should be updated. Note the
Disposition Follow Up
(FUP) Date of
Completion/Discontinuation
/Death is 10/Feb/2021, and
the stop of the fatal event is
10Feb2021.
Feb-17-2021 02:31:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please report
cause of death. Note:
Bacterial Pneumonia is
reported with a fatal
outcome.
Feb-15-2021 14:17:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/9/2021Transcription Error
Feb-15-2021 10:24:44
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
Feb-15-2021 10:23:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Jan-18-2021 16:28:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Feb-17-2021 10:29:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Cause of Deat
h Status:PRIMARY CAUSE
OF DEATH
Cause of Deat
h:Bacterial pneumoniaInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Feb-17-2021 10:29:27 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0821051
Page 158 of 166
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul PRIMARY CAUSE OF DEATH
2.a Cause of Death:
Date Location User Value Reason
Feb-17-2021 10:29:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Bacterial pneumoniaInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821052
Page 159 of 166
***Confidential***
 
Header Text  C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 14:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 14:02:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Mar-05-2021 20:56:39
(UTC+03:00) IstanbulACV0PFEINFP6000  Rivkah Rosen Query 1: Closed Response satisfies
query
Mar-04-2021 10:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered form 1 was completed
on 18jan2021 subject
unblinded was done.
but V101 could not
done due to subject
page. Disposition page
can not be erased
because this procedure
is done allready
instead of deleting
page V101 page filled
as not done.
Mar-03-2021 20:39:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened DM Q: If not
occurred, kindly erase
the data from DISP
RESCR form and add
form level comment as
Not Done or Not
Applicable or else
clarify.
Mar-03-2021 15:28:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered V101 visit haven't
done because of
subject death but
before the subject's
death, disposition page
was allready filled.
Should i still delete the
page?
Mar-02-2021 15:15:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened DOV is marked as Not
Done. Please confirm
if this visit occurred. If
yes, update the DOV
as appropriate. If not
occurred, kindly erase
the data from DISP
RESCR form and add
form level comment as
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821053
Page 160 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Not Done or Not
Applicable or else
clarify.
Feb-11-2021 12:26:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-09-2021 14:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 14:02:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Feb-11-2021 12:26:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821054
Page 161 of 166
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-11-2021 12:27:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821055
Page 162 of 166
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 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
Feb-18-2021 18:07:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 11:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-18-2021 11:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/9/2021Transcription Error
Feb-18-2021 10:57:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Date is reported at
disposition follow up
CRF is 09Feb2021,
hence, please confirm
whether this dates
needs to be updated to
09Feb2021. Else
clarify.
Feb-11-2021 12:28:08
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-11-2021 12:28:08
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 18:36:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Mar-12-2021 14:57:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 4: Answered Subject died but
disposition was done
before his death.
Mar-12-2021 14:40:59
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 4: Opened DM: Status reported as
Death. However,
Death details are
present on DEATH
DTL and DISP FUP
forms. As this visit is
not occur, kindly
consider to erase data
from this form and
mark this form as Not
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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-2021-5683-0821056
Page 163 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Done/Not Applicable
at form level comment
else, clarify.
Mar-09-2021 20:01:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-09-2021 20:00:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Mar-09-2021 14:06:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Answered visit did not occur but
this page needs to be
filled according to data
manager.
Mar-09-2021 14:05:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 3: Answered subject died due to
SAE
Mar-09-2021 14:03:57
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status" is
DEATH but "Specify
Status" is Provided.
Mar-08-2021 12:54:44
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened DM: DOV form is
marked as Not Done.
Please confirm if this
visit occurred. If yes,
update the DOV form
as appropriate. If not
occurred, kindly erase
the data from this form
and add form level
comment as Not Done
or Not Applicable or
else clarify.
Feb-16-2021 22:29:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-16-2021 09:28:01
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-15-2021 19:37:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened DM: The Death
Details page is located
under Disposition.
Feb-12-2021 11:37:23
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered Death detail page is
not available on crf.
could you please add
the relevant page?
Feb-12-2021 02:13:52
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened DM RQ: Per the
CRFCR, if a
participant ends the
study due to death,
The Death Details
Coded (DEATH DTL)
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (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)
FDA-CBER-2021-5683-0821057
Page 164 of 166
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
CRF is required to be
completed. Currently,
the CRF is not
completed. Please
review and update
accordingly.
Feb-11-2021 12:32:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered SAE FU report will be
submitted within today
Feb-11-2021 12:28:08
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Response to 'Status' is
'Death' on Disposition-
Follow up, but 'Death'
CRF is not yet
initiated. Please review
and update as
appropriate.
Feb-11-2021 12:28:08
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-09-2021 14:03:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
visit did not occur because of subject d
eath. this page needs to be complete.Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0821058
Page 165 of 166
***Confidential***
 
Header Text  C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Feb-11-2021 11:54:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPTranscription Error
Feb-11-2021 11:53:22
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDNew Information
Jan-19-2021 12:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-05-2020 14:47:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-05-2020 14:39:45
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-17-2021 10:25:28
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/9/2021Transcription Error
Feb-11-2021 12:29:00
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/10/2021Initial Entry
Feb-11-2021 11:54:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/14/2021Transcription Error
Feb-11-2021 11:54:18
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/14/2021Transcription Error
Feb-11-2021 11:53:22
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/10/2021New Information
Feb-11-2021 11:52:52
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/10/2021New Information
Jan-19-2021 12:48:47
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/14/2021Transcription Error
Jan-19-2021 12:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/19/2021Initial Entry
Nov-05-2020 14:47:23
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Nov-05-2020 14:39:45
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821059
Page 166 of 166
***Confidential***
 
Header Text  C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1207 Site Name: (1207) Ankara University Medical Faculty
Subject No: 12071055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-09-2020 22:03:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4002\Final\Final On: 01-Apr-2021 05:28 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821060