Document text
Page 1 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989187
Page 2 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/10/2020
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989188
Page 3 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12051075]
2.Birth Date: 1973
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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989189
Page 4 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989190
Page 5 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989191
Page 6 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989192
Page 7 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989193
Page 8 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989194
Page 9 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
2.Weight: [75.0]
3.Unit: kg
4.Height: [171.0]
5.Unit: cm
6.Body Mass Index: [25.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989195
Page 10 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/10/2020
2.Randomization Number: [116062]
3.Randomization Group: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989196
Page 11 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BRDH54]
5.bSample ID [BRDH55]
5.cSample ID [BSHR2Z]
5.dSample ID [BSHR30]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989197
Page 12 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BRDH4Z]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989198
Page 13 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/10/2020 14:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989199
Page 14 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989200
Page 15 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989201
Page 16 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989202
Page 17 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989203
Page 18 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989204
Page 19 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/1/2020
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 [BR5PLJ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989205
Page 20 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/1/2020 11:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989206
Page 21 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989207
Page 22 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989208
Page 23 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989209
Page 24 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8XCT]
5.bSample ID [BN8XCS]
5.cSample ID [BNM4WN]
5.dSample ID [BNM4WM]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989210
Page 25 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989211
Page 26 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989212
Page 27 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989213
Page 28 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989214
Page 29 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989215
Page 30 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989216
Page 31 of 125
***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: 12051075 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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989217
Page 32 of 125
***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: 12051075 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: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989218
Page 33 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989219
Page 34 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989220
Page 35 of 125
***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: 12051075 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?
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989221
Page 36 of 125
***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: 12051075 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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989222
Page 37 of 125
***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: 12051075 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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989223
Page 38 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989224
Page 39 of 125
***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: 12051075 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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989225
Page 40 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989226
Page 41 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identifie
rAdverse Eve
ntStart DateIs the Adverse Event Still Ongoi
ngForm Instance
1.ADVERSE EVEN
T 1 Anal Abscess Jan/4/2021 UNK:UN
K NO
End Date Time:
Jan/6/2021 UNK:UNK
Repeating Pages
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989227
Page 42 of 125
***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: 12051075 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)[Anal Abscess]
4.Start Date Time: Jan/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Anal Abscess]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989228
Page 43 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021037960]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989229
Page 44 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ongo
ingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989230
Page 45 of 125
***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: 12051075 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[ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989231
Page 46 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989232
Page 47 of 125
***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: 12051075 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: //
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989233
Page 48 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989234
Page 49 of 125
***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: 12051075 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?
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989235
Page 50 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989236
Page 51 of 125
***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: 12051075 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?
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989237
Page 52 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989238
Page 53 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989239
Page 54 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989240
Page 55 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989241
Page 56 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989242
Page 57 of 125
***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: 12051075 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:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989243
Page 58 of 125
***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: 12051075 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?
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989244
Page 59 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989245
Page 60 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989246
Page 61 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989247
Page 62 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989248
Page 63 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989249
Page 64 of 125
***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: 12051075 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 [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989250
Page 65 of 125
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/11/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989251
Page 66 of 125
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989252
Page 67 of 125
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989253
Page 68 of 125
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989254
Page 69 of 125
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989255
Page 70 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989256
Page 71 of 125
***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: 12051075 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: [ ]
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989257
Page 72 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/11/2021
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989258
Page 73 of 125
***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: 12051075 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
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989259
Page 74 of 125
***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: 12051075 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 13:41:57 (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.
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989260
Page 75 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-10-2020 16:29:09 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989261
Page 76 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-10-2020 16:29:59 (UTC+03:00) Istanbul Not Applicable
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989262
Page 77 of 125
***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: 12051075 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 13:41:57 (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.
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989263
Page 78 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-10-2020 16:26:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-10-2020 16:26:42
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0989264
Page 79 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-10-2020 16:27:08
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/10/2020Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989265
Page 80 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-10-2020 16:26:22
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12051075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-10-2020 16:26:18
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-10-2020 16:28:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-10-2020 16:28:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-10-2020 16:28:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f2f\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-2021-5683-0989266
Page 81 of 125
***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: 12051075 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-10-2020 16:28:55
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989267
Page 82 of 125
***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: 12051075 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-10-2020 16:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-10-2020 16:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-10-2020 16:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989268
Page 83 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-10-2020 16:30:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV P
OSITIVEInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989269
Page 84 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
75.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
171.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.6Initial Entry
7.a
Date Location User Value Reason
090177e196ae3f2f\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-2021-5683-0989270
Page 85 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Location:
:FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-10-2020 16:31:07
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f2f\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-2021-5683-0989271
Page 86 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-10-2020 16:56:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-10-2020 16:56:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
116062Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989272
Page 87 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 16:35:49
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 16:35:49
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 16:36:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 16:35:49
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-10-2020 16:35:49
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020 16:36:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BRDH54Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 16:36:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BRDH54Initial Entry
5.b
090177e196ae3f2f\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-2021-5683-0989273
Page 88 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-10-2020 16:36:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BRDH55Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-10-2020 16:36:46
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BRDH55Initial Entry
5.c
Date Location User Value Reason
Nov-10-2020 16:37:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHR2ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-10-2020 16:37:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHR2ZInitial Entry
5.d
Date Location User Value Reason
Nov-10-2020 16:37:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BSHR30Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-10-2020 16:37:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BSHR30Initial Entry
090177e196ae3f2f\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-2021-5683-0989274
Page 89 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 16:34:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 16:34:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 16:35:30
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 16:34:39
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-10-2020 16:34:39
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020 16:35:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BRDH4ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 16:35:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BRDH4ZInitial Entry
090177e196ae3f2f\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-2021-5683-0989275
Page 90 of 125
***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: 12051075 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-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020 14:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f2f\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-2021-5683-0989276
Page 91 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-10-2020 16:31:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989277
Page 92 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-10-2020 16:32:03
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989278
Page 93 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-01-2020 11:23:27
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/1/2020Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989279
Page 94 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989280
Page 95 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILLInitial Entry
090177e196ae3f2f\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-2021-5683-0989281
Page 96 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
090177e196ae3f2f\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-2021-5683-0989282
Page 97 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989283
Page 98 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3f2f\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-2021-5683-0989284
Page 99 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Injection Site Body Side:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989285
Page 100 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-01-2020 11:24:00
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989286
Page 101 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/1/2020Initial Entry
2.a
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Location:
:FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-01-2020 11:24:26
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f2f\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-2021-5683-0989287
Page 102 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-01-2020 11:24:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-01-2020 11:24:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-01-2020 11:25:14
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-01-2020 11:24:53
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-01-2020 11:24:53
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/1/2020Initial Entry
5.a
Date Location User Value Reason
Dec-01-2020 11:25:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BR5PLJInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-01-2020 11:25:14
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BR5PLJInitial Entry
090177e196ae3f2f\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-2021-5683-0989288
Page 103 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Dec/1/2020 11:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f2f\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-2021-5683-0989289
Page 104 of 125
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-01-2020 11:42:34
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989290
Page 105 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-18-2021
10:15:53
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Clo
sedAs per site confirmation -
updated PD tracker
Jan-15-2021
11:01:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
1: Ans
weredThe original Value is correct.
This volunteer can not join this
visit due to his personal issues
till 05.Jan.2021 which was the
latest expected V3 date as per
protocol.
Jan-13-2021
15:03:23
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
2: Clo
sedClosed as data entered.
Jan-12-2021
16:52:41
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
2: Ans
weredUpdated.
Jan-12-2021
13:28:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query
2: Op
enedDM: The treatment period is
defined as 1st vaccination visit
through the 1-month post
vaccination visit after the 2nd
vaccination. Please complete
treatment disposition CRF and
update date of EOT to match
date of visit at visit 3.
Jan-12-2021
10:26:53
(UTC+03:00)
IstanbulACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 6 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Jan-11-2021
11:37:38
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data
Entry
:
Jan/11
/2021Initial Entry
090177e196ae3f2f\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)
(b) (4)
FDA-CBER-2021-5683-0989291
Page 106 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989292
Page 107 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILLInitial Entry
090177e196ae3f2f\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-2021-5683-0989293
Page 108 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
090177e196ae3f2f\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-2021-5683-0989294
Page 109 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f2f\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), (b)
(6)
FDA-CBER-2021-5683-0989295
Page 110 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.g Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3f2f\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-2021-5683-0989296
Page 111 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Injection Site Body Side:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989297
Page 112 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 11:38:25
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989298
Page 113 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 11:38:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 11:38:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021 11:39:15
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-11-2021 11:38:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-11-2021 11:38:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 11:39:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BN8XCTInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 11:39:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BN8XCTInitial Entry
5.b
090177e196ae3f2f\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-2021-5683-0989299
Page 114 of 125
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-11-2021 11:39:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BN8XCSInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-11-2021 11:39:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BN8XCSInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 11:39:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BNM4WNInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-11-2021 11:39:54
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BNM4WNInitial Entry
5.d
Date Location User Value Reason
Jan-11-2021 11:40:10
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Sample ID: BNM4WMInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-11-2021 11:40:10
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
BNM4WMInitial Entry
090177e196ae3f2f\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-2021-5683-0989300
Page 115 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989301
Page 116 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021 12:58:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021 12:58:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-19-2021 12:58:48
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Anal AbscessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Jan/4/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/6/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-21-2021 19:13:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-21-2021 15:11:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-21-2021 15:11:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2Transcription Error
090177e196ae3f2f\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989302
Page 117 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-20-2021 07:14:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Please
assess if this SAE was
more severe than
Grade 1.
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-20-2021 15:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 12:58:48
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Anal
Abscess: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NOInitial Entry
090177e196ae3f2f\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-2021-5683-0989303
Page 118 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Is this serious event life threatening
?
NO
Other medically important serious e
vent
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.
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-19-2021 13:02:01
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
Anal AbscessTranscription Error
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3f2f\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-2021-5683-0989304
Page 119 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-21-2021 19:12:45
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-21-2021 13:05:56
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-21-2021 13:05:56
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
YESTranscription Error
Jan-20-2021 07:13:44
(UTC+03:00) IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Per SAE
report, the subject was
hospitalized and had
perianal abscess
drainage operation. If
that's correct, please
change to "Yes" here.
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021 12:56:15
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-20-2021 15:15:51
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
2021037960Initial Entry
090177e196ae3f2f\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)
(b) (4)
FDA-CBER-2021-5683-0989305
Page 120 of 125
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 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
Jan-12-2021 16:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-12-2021 16:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-12-2021 16:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989306
Page 121 of 125
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-15-2021 10:02:30
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989307
Page 122 of 125
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021 12:16:38
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-18-2021 11:12:20
(UTC+03:00) IstanbulACV0PFEINFP6000 Query 1: Opened The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-15-2021 10:02:41
(UTC+03:00) IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-15-2021 10:02:41
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vacci
nation 1/2Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989308
Page 123 of 125
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-18-2021 12:16:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-18-2021 12:16:38
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989309
Page 124 of 125
***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: 12051075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-12-2021 16:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-10-2020 16:56:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-10-2020 16:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-12-2021 16:49:05
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/11/2021Initial Entry
Nov-10-2020 16:56:32
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/10/2020Initial Entry
Nov-10-2020 16:29:40
(UTC+03:00) IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989310
Page 125 of 125
***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: 12051075 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 14:54:57
(UTC+03:00) IstanbulACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f2f\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989311