125742 S1 M5 CRF c4591001 1205 12051028

Document text

Page 1 of 127
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989060
Page 2 of 127
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/30/2020
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989061
Page 3 of 127
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12051028]
2.Birth Date: 1982
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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989062
Page 4 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989063
Page 5 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989064
Page 6 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED Comments
4.Specify Status: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989065
Page 7 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989066
Page 8 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989067
Page 9 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/30/2020
2.Weight: [64.0]
3.Unit: kg
4.Height: [156.0]
5.Unit: cm
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989068
Page 10 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/30/2020
2.Randomization Number: [114959]
3.Randomization Group: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989069
Page 11 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDH0F]
5.bSample ID [BRDH0G]
5.cSample ID [BSHR08]
5.dSample ID [BSHR09]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989070
Page 12 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDH04]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989071
Page 13 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989072
Page 14 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989073
Page 15 of 127
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989074
Page 16 of 127
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions present
on the last day the Subject Diary
was completed?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989075
Page 17 of 127
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989076
Page 18 of 127
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989077
Page 19 of 127
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989078
Page 20 of 127
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989079
Page 21 of 127
***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: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions present
on the last day the Subject Diary
was completed?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989080
Page 22 of 127
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989081
Page 23 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989082
Page 24 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989083
Page 25 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989084
Page 26 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989085
Page 27 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989086
Page 28 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989087
Page 29 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989088
Page 30 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989089
Page 31 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989090
Page 32 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989091
Page 33 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989092
Page 34 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989093
Page 35 of 127
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989094
Page 36 of 127
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989095
Page 37 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989096
Page 38 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989097
Page 39 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Increasing of systolic and diastolic
blood pressure Oct/30/2020
14:55 NO
End Date Time:
Oct/30/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989098
Page 40 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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)[Increasing of systolic and diastolic blood pressure]
4.Start Date Time: Oct/30/2020 14:55
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Blood pressure values of volunteer were high during vaccine preparation period.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989099
Page 41 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989100
Page 42 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989101
Page 43 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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[ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989102
Page 44 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989103
Page 45 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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: //
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989104
Page 46 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989105
Page 47 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989106
Page 48 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989107
Page 49 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989108
Page 50 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989109
Page 51 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989110
Page 52 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989111
Page 53 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989112
Page 54 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989113
Page 55 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989114
Page 56 of 127
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989115
Page 57 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989116
Page 58 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989117
Page 59 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989118
Page 60 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989119
Page 61 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989120
Page 62 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989121
Page 63 of 127
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989122
Page 64 of 127
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989123
Page 65 of 127
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989124
Page 66 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 :Oct/30/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989125
Page 67 of 127
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989126
Page 68 of 127
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989127
Page 69 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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 Oct/30/2020
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989128
Page 70 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989129
Page 71 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
Serhat Unal  Approved Feb-22-2021 13:08:49 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SerhatUnal, 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.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989130
Page 72 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 15:01:28 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989131
Page 73 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Oct-30-2020 18:41:23 (UTC+03:00) Istanbul The Subject is discontinued by Physician.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989132
Page 74 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-30-2020 15:13:51 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989133
Page 75 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989134
Page 76 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989135
Page 77 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989136
Page 78 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989137
Page 79 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989138
Page 80 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989139
Page 81 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989140
Page 82 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989141
Page 83 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989142
Page 84 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989143
Page 85 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989144
Page 86 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
11Nov-03-2020 16:55:56 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
Not Done
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989145
Page 87 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-13-2020 15:51:34 (UTC+03:00) Istanbul Volunteer discontinued by investigator due to
an AE was occurred during vaccine
preparation period.
Not Applicable
FormNov-12-2020 12:11:41 (UTC+03:00) Istanbul
FormNov-12-2020 08:32:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989146
Page 88 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-13-2020 15:51:34 (UTC+03:00) Istanbul Volunteer discontinued by investigator due to
an AE was occurred during vaccine
preparation period.
Not Applicable
1Nov-12-2020 12:11:41 (UTC+03:00) Istanbul
1Nov-12-2020 08:32:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989147
Page 89 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-13-2020 15:51:34 (UTC+03:00) Istanbul Volunteer discontinued by investigator due to
an AE was occurred during vaccine
preparation period.
Not Applicable
2Nov-12-2020 12:11:41 (UTC+03:00) Istanbul
2Nov-12-2020 08:32:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989148
Page 90 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-13-2020 15:51:34 (UTC+03:00) Istanbul Volunteer discontinued by investigator due to
an AE was occurred during vaccine
preparation period.
Not Applicable
3Nov-12-2020 12:11:41 (UTC+03:00) Istanbul
3Nov-12-2020 08:32:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989149
Page 91 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-13-2020 15:51:34 (UTC+03:00) Istanbul Volunteer discontinued by investigator due to
an AE was occurred during vaccine
preparation period.
Not Applicable
4Nov-12-2020 12:11:41 (UTC+03:00) Istanbul
4Nov-12-2020 08:32:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989150
Page 92 of 127
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-03-2020 16:49:39 (UTC+03:00) Istanbul Since the blood pressure values of volunteer were
high during vaccine preparation period, it was
decided to not continue the study by decision of
investigator.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989151
Page 93 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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
Serhat Unal  Approved Feb-22-2021 13:08:49 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SerhatUnal, 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.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989152
Page 94 of 127
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-30-2020 14:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-30-2020 14:41:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0989153
Page 95 of 127
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-30-2020 14:42:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/30/2020Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989154
Page 96 of 127
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-30-2020 14:41:18
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12051028Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 14:41:13
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020 14:42:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-30-2020 14:42:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-30-2020 14:42:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989155
Page 97 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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-04-2020 09:43:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-03-2020 16:56:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered Vaccination and
Randomization forms
were updated.
Nov-03-2020 15:50:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete
‘Vaccination and
Randomization form'
at this visit. Thank
you.
Oct-30-2020 15:01:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989156
Page 98 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-30-2020 15:13:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 15:13:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020
11:20:38
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Clos
edResponse
satisfies query
Nov-03-2020
16:53:07
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Ans
weredRandomization
and Follow-Up
Disposition forms
were updated.
Nov-03-2020
15:51:23
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Reis
sued:OpenedIVRS RQ2:
Randomization
number and date
is recorded at
impala but
missing in
Inform. Please
update
'Randomization'
form to complete.
Also, withdrawal
information to be
completed at
'Follow-up
disposition form.
Nov-02-2020
17:05:22
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 3: Ans
weredChanged
Information
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989157
Page 99 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-02-2020
17:05:22
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
COMPLETE
DChanged
Information
Nov-02-2020
15:53:19
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Reis
sued:OpenedIVRS RQ1:
Randomization
number and date
is recorded at
impala but
missing in
Inform. Please
mark status as
'Completed' here,
which will open
'Randomization'
form to complete.
study
discontinuation
information to be
updated at
FU-DS form per
CCG sec 5.3.
Nov-02-2020
14:53:05
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query 3: Ans
weredSince the blood
pressure values of
the volunteer
were high, it was
decided not to
continue the
study with the
decision of the
investigator.
Nov-02-2020
14:52:49
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 4: Clos
edClose Auto
Query
Nov-02-2020
14:52:26
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 4: Ope
nedResponse to
"Status" is
PHYSICIAN
DECISION but
"Specify Status"
is Provided.
Nov-02-2020
12:28:20
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 3: Ope
nedAs per Impala,
Subject status is
Discontinued.
Please review and
update as
appropriate.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989158
Page 100 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Thank you.
Oct-30-2020
18:40:51
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Clos
edClose Auto
Query
Oct-30-2020
18:40:28
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Ope
nedResponse to
"Status" is
PHYSICIAN
DECISION but
"Specify Status"
is Provided.
Oct-30-2020
18:40:28
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
PHYSICIAN
DECISIONInitial Entry
Oct-30-2020
18:40:09
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Clos
edClose Auto
Query
Oct-30-2020
18:40:09
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry: Transcription
Error
Oct-30-2020
18:36:12
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
nedResponse to
"Status" is
PHYSICIAN
DECISION but
"Specify Status"
is Provided.
Oct-30-2020
16:18:53
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
PHYSICIAN
DECISIONNew Information
Oct-30-2020
15:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data Entry:
COMPLETE
DInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-02-2020 14:52:49 ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989159
Page 101 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul
Nov-02-2020 14:52:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Since the blood pressure values of t
he volunteer were high, it was decid
ed not to continue the studyInitial Entry
Oct-30-2020 18:40:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Oct-30-2020 18:36:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Subject is discontinued by Physicia
n.Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989160
Page 102 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-30-2020 15:14:21
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989161
Page 103 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
64.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
156.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.3Initial Entry
7.a
Date Location User Value Reason
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989162
Page 104 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020 15:15:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989163
Page 105 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-03-2020 16:41:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-03-2020 16:41:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
114959Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989164
Page 106 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 15:25:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 15:25:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 15:26:06
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 15:25:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-30-2020 15:25:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 15:26:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDH0FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 15:26:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDH0FInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989165
Page 107 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b
Date Location User Value Reason
Oct-30-2020 15:26:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDH0GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 15:26:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDH0GInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020 15:26:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHR08Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 15:26:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHR08Initial Entry
5.d
Date Location User Value Reason
Oct-30-2020 15:26:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHR09Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 15:26:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHR09Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989166
Page 108 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 15:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 15:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 15:23:07
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 15:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-30-2020 15:22:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 15:23:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BRDH04Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 15:23:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BRDH04Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989167
Page 109 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-05-2020
20:38:26
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-04-2020
15:20:47
(UTC+03:00)
IstanbulACV0PFEINFP6000  Query
1: Ans
weredSince the blood pressure
values of volunteer were high
during vaccine preparation
period, it was decided to not
continue the study by decision
of investigator.
Nov-03-2020
23:43:21
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5269481;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Nov-03-2020
16:55:56
(UTC+03:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989168
Page 110 of 127
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul Not D
one
5. Anatomical Location:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-03-2020 16:55:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989169
Page 111 of 127
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-30-2020 15:15:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989170
Page 112 of 127
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989171
Page 113 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Increasing of systolic and diastolic bl
ood pressureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020 14:55Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-07-2020
06:04:48
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2
: ClosedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-07-2020
01:03:30
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2
: Answe
redTranscription Error
Nov-07-2020
01:03:30
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data E
ntry:
NO
End D
ate Ti
me:Transcription Error
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989172
Page 114 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct/
30/2
020
UN
K:U
NK
Nov-07-2020
00:16:54
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2
: Opene
dDMW5305403;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-06-2020
13:26:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1
: ClosedClose Auto Query
Nov-06-2020
13:26:42
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data E
ntry:
NO
End D
ate Ti
me:
Nov/
5/20
20 U
NK:
UN
KNew Information
Nov-06-2020
13:13:30
(UTC+03:00)
IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1
: Opene
d'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Nov-06-2020
13:13:30
(UTC+03:00)
IstanbulACV0PFEINFP6000  Data E
ntry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 18:35:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989173
Page 115 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-12-2020 17:08:02
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Updated.
Nov-12-2020 17:08:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Updated.
Nov-12-2020 13:13:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened clinical query: The
toxicity grade is
expected per CCG
guidelines. Please
complete this field
selecting a number
from 1 to 5 as
appropriate where 1
stand for MILD, does
not interfere with
participant's usual
function, 2 stand for
MODERATE, 3
SEVERE....
Nov-12-2020 12:10:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Any Toxicity Grade
can not be evaluated
by investigator due to
vaccination can not be
performed for this
volunteer.
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989174
Page 116 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-06-2020 13:23:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
Blood pressure values of volu
nteer were high during vaccine
preparation period.Transcription Error
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 18:35:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-12-2020 17:09:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Updated.
Nov-12-2020 17:09:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEUpdated.
Nov-12-2020 13:15:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened clinical query: to close
this query please
change latest action
taken with study
treatment from drug
withdrawn to not
applicable as the
subject was never
vaccinated. Thanks
Nov-12-2020 12:16:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered The EoT page wa
updated accordingly.
Nov-12-2020 09:29:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened DM: EOT page is still
not updated. As Latest
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989175
Page 117 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Action Taken with
Study Treatment is
reported as DRUG
WITHDRAWN,
However, the EOT
page is not completed.
Please complete EOT
page indicating
Subject discontinued
due to AE.
Nov-11-2020 08:33:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered EOT page is updated
Nov-11-2020 07:15:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened Latest Action Taken
with Study Treatment:
DRUG
WITHDRAWN,
However, the EOT
page is not completed.
Please complete EOT
page indicated Subject
discontinued due to
AE on 30OCT2020.
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-06-2020 13:27:17
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-06-2020 13:27:17
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989176
Page 118 of 127
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-06-2020 13:26:42
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Increasing of
systolic and diastolic
blood pressure:
Response to "What
was the outcome of
this adverse event?" is
'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Nov-06-2020 13:14:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020 13:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989177
Page 119 of 127
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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-13-2020 19:09:49
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 15:51:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-13-2020 15:48:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 15:48:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-12-2020 13:18:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Reissued:Opened clinical query: per
CCG guidelines this
page should be
completed only when
a subject receive at
least one dose. As the
subject was not
vaccinated please
mark this page as not
applicable and the
query will be closed.
thanks.
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
Nov-12-2020 12:11:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Nov-12-2020 08:32:59
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered completed
Nov-12-2020 08:32:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-12-2020 07:34:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened DM: Per status,
subject is
discontinued from the
treatment if correct,
kindly consider
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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)
FDA-CBER-2021-5683-0989178
Page 120 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
marking Not
Applicable on this
form by selecting
form level comment
or else clarifying.
Thank you.
Nov-11-2020 14:20:40
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-11-2020 08:32:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-13-2020 15:51:34
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-13-2020 15:48:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Nov-12-2020 12:11:41
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Nov-12-2020 08:32:33
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 14:20:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Nov-11-2020 08:32:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020 15:51:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-13-2020 15:51:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-13-2020 15:51:10
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989179
Page 121 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020 15:50:46
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is OTHER but
"Specify Status" is
missing.
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
Nov-12-2020 12:11:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Nov-12-2020 08:32:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-11-2020 16:16:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-11-2020 14:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-11-2020 14:22:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PHYSICIAN DECISIONInitial Entry
Nov-11-2020 14:21:07
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-11-2020 14:21:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-11-2020 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Opened clinical query: as per
CCG guidelines EOT
page should not be
completed for patient
who has not received
the vaccination.
Please delete this
entry. thanks
Nov-11-2020 08:32:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PHYSICIAN DECISIONInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-13-2020 15:51:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989180
Page 122 of 127
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020 15:50:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Volunteer discontinued by investigat
or due to an AE was occurred during
vaccine preparation period.Initial Entry
Nov-12-2020 12:11:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Initial Entry
Nov-12-2020 08:32:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0989181
Page 123 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 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-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-14-2020 11:53:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-13-2020 15:52:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Nov-13-2020 15:52:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Nov-12-2020 13:13:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Reissued:Opened DM: FUP CRF is
unfrozen. Subject was
discontinued due to
the Adverse Event as
per AE details. Please
make all applicable
updates to the FUP
page. Thank You!
Nov-11-2020 08:54:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Answered We filled out the FUP
and Logs pages.
Nov-11-2020 07:18:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened Physician decision is
check as reason for
discontinuation.
However, the Adverse
Event has indicated
that the subject was
discontinued due to
the Adverse Event.
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0989182
Page 124 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Please make all
applicable updates to
the FUP page. Thank
You!
Nov-03-2020 16:47:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PHYSICIAN DECISIONInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-03-2020 16:47:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Since the blood pressure values of th
e volunteer were high during vaccin
e preparation period.Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989183
Page 125 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-13-2020 15:52:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-13-2020 15:51:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-11-2020 14:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-11-2020 14:22:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-11-2020 14:21:07
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-11-2020 08:32:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-03-2020 16:41:36
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-02-2020 17:05:22
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDChanged Information
Oct-30-2020 18:40:28
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREEN FAILInitial Entry
Oct-30-2020 18:40:09
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 16:18:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREEN FAILNew Information
Oct-30-2020 15:13:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-13-2020 15:52:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Changed Information
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989184
Page 126 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020 15:51:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Transcription Error
Nov-13-2020 15:48:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Transcription Error
Nov-12-2020 12:15:54
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Nov-11-2020 14:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Transcription Error
Nov-11-2020 14:22:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Nov-11-2020 14:21:07
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Transcription Error
Nov-11-2020 14:20:40
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Transcription Error
Nov-11-2020 08:32:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Nov-03-2020 16:46:26
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Nov-03-2020 16:41:36
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Nov-02-2020 17:05:22
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Changed Information
Oct-30-2020 18:40:28
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Oct-30-2020 18:40:09
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 16:18:53
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020New Information
Oct-30-2020 15:13:10
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989185
Page 127 of 127
***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-02-2020 14:37:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f30\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989186