Document text
Page 1 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919574
Page 2 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/16/2020
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919575
Page 3 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10711172]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919576
Page 4 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919577
Page 5 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919578
Page 6 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919579
Page 7 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYSTERECTOMY]
Start Date: Aug/UNK/2007
Ongoing: NO
End Date:
Aug/UNK/2007
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[POSTMENOPAUSAL]
Start Date: UNK/UNK/2007
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OBESITY]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919580
Page 8 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [116.1]
3.Unit: kg
4.Height: [154.9]
5.Unit: cm
6.Body Mass Index: [48.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919581
Page 9 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919582
Page 10 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [260323]
3.Randomization Group: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919583
Page 11 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPTLBB]
5.bSample ID [BPRKCY]
5.cSample ID [BPRKCZ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919584
Page 12 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPTLB8]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919585
Page 13 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: Sep/16/2020 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919586
Page 14 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919587
Page 15 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919588
Page 16 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919589
Page 17 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919590
Page 18 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTLG5]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919591
Page 19 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/5/2020 13:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919592
Page 20 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919593
Page 21 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
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 [BRJ0X8]
5.bSample ID [BSMZL9]
5.cSample ID [BSMZLB]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919594
Page 22 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919595
Page 23 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919596
Page 24 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919597
Page 25 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919598
Page 26 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919599
Page 27 of 195
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919600
Page 28 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919601
Page 29 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919602
Page 30 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919603
Page 31 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919604
Page 32 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919605
Page 33 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919606
Page 34 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 MENTAL CO
NFUSION Feb/27/2021
UNK:UNK NO
End Date Time:
Feb/27/2021 UNK
:UNK
Repeating
Pages
2.ADVERSE
EVENT 2 HYPERTENS
ION Feb/27/2021
UNK:UNK NO
End Date Time:
Feb/28/2021 UNK
:UNK
Repeating
Pages
3.ADVERSE
EVENT 3 HYPERTENS
ION Feb/28/2021
UNK:UNK YES Repeating
Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919607
Page 35 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[MENTAL CONFUSION]
4.Start Date Time: Feb/27/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919608
Page 36 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919609
Page 37 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919610
Page 38 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[HYPERTENSION]
4.Start Date Time: Feb/27/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/28/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919611
Page 39 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919612
Page 40 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021253124]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919613
Page 41 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[HYPERTENSION]
4.Start Date Time: Feb/28/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919614
Page 42 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919615
Page 43 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919616
Page 44 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919617
Page 45 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919618
Page 46 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-D
efined Ide
ntifierCategory
for Medic
ationConcomitant
Medications Pr
e-specifiedName of MedicationStart
DateForm Insta
nce
1.1 VACCINA
TIONS NO FLU ZONE HIGH DOSE
PROPHYLAXIS INFLUE
NZA VACCINE Oct/2
7/202
0 Repeating
Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919619
Page 47 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[FLU ZONE HIGH DOSE PROPHYLAXIS INFLUENZA
VACCINE]
5.Date: Oct/27/2020
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919620
Page 48 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919621
Page 49 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919622
Page 50 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919623
Page 51 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919624
Page 52 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919625
Page 53 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919626
Page 54 of 195
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919627
Page 55 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919628
Page 56 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919629
Page 57 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919630
Page 58 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919631
Page 59 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919632
Page 60 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919633
Page 61 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919634
Page 62 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919635
Page 63 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919636
Page 64 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/30/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919637
Page 65 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919638
Page 66 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919639
Page 67 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/30/2021
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919640
Page 68 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/30/2021
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919641
Page 69 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919642
Page 70 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/30/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919643
Page 71 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/30/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919644
Page 72 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/30/2021
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 [BPTLX5]
5.bSample ID [BSGS99]
5.cSample ID [BSGS9B]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919645
Page 73 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/30/2021
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 [BPTLWR]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919646
Page 74 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/30/2021 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919647
Page 75 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919648
Page 76 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/20/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919649
Page 77 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/20/2021
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 [BRMM3B]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919650
Page 78 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/20/2021 14:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919651
Page 79 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919652
Page 80 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919653
Page 81 of 195
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919654
Page 82 of 195
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919655
Page 83 of 195
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919656
Page 84 of 195
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919657
Page 85 of 195
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919658
Page 86 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/2/2020
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919659
Page 87 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919660
Page 88 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dunn Approved Mar-10-2021 10:16:12 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919661
Page 89 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-17-2020 10:15:32 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919662
Page 90 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-31-2021 10:22:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919663
Page 91 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dunn Approved Mar-10-2021 10:16:12 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Jan-31-2021 10:21:29 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dunn Approved Nov-09-2020 16:13:07 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919664
Page 92 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919665
Page 93 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-17-2020
10:14:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Transcription
Error
Sep-17-2020
10:14:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-17-2020
10:14:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919666
Page 94 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020
10:14:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/16/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919667
Page 95 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020
10:14:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10711172Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020
10:14:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1956Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020
10:15:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919668
Page 96 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-17-2020
10:15:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020
10:15:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919669
Page 97 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
10:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919670
Page 98 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-17-2020
10:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020
10:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020
10:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919671
Page 99 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
10:16:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:HYSTER
ECTOMY
Start Date
:Aug/UNK/
2007
Ongoing: NO
End Date
:
Aug/U
NK/200
7Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020
10:16:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919672
Page 100 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-17-2020
10:16:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HYSTERECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020
10:16:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2007Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020
10:16:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2007Initial Entry
1.b
Date Location User Value Reason
Sep-17-2020
10:16:38
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919673
Page 101 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada) Medical H
istory Ter
m:POSTME
NOPAUS
AL
Start Date
:UNK/UN
K/2007
Ongoing: YES
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919674
Page 102 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020
10:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
10:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
POSTMENOPAUSA
LInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020
10:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-17-2020
10:16:38ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919675
Page 103 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-17-2020
10:16:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:OBESIT
Y
Start Date: UNK/U
NK/198
0
Ongoing: YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919676
Page 104 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020
10:16:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
10:16:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBESITYInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020
10:16:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-17-2020
10:16:53ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919677
Page 105 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919678
Page 106 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
116.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919679
Page 107 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
154.9Initial Entry
5. Unit:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48.4Initial Entry
7.a
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919680
Page 108 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919681
Page 109 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
10:17:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919682
Page 110 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919683
Page 111 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919684
Page 112 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020
10:17:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919685
Page 113 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020
10:17:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020
10:17:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
260323Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919686
Page 114 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
10:17:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
10:17:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
10:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
10:17:54
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919687
Page 115 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
10:17:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
10:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPTLB
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
10:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPTLBBInitial Entry
5.b
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919688
Page 116 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-17-2020
10:18:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPRKC
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020
10:18:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPRKCYInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020
10:18:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPRKC
ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020
10:18:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPRKCZInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919689
Page 117 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
10:18:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
10:18:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
10:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
10:18:30
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919690
Page 118 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
10:18:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
10:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPTLB
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
10:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPTLB8Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919691
Page 119 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919692
Page 120 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 11:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919693
Page 121 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-17-2020
10:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919694
Page 122 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-17-2020
10:19:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919695
Page 123 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
09:59:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919696
Page 124 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.3
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919697
Page 125 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-06-2020
09:59:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919698
Page 126 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919699
Page 127 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919700
Page 128 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-06-2020
09:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919701
Page 129 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
09:59:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
09:59:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
09:59:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
09:59:32
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919702
Page 130 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
09:59:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
09:59:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPTLG
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
09:59:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPTLG5Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919703
Page 131 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919704
Page 132 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919705
Page 133 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-06-2020
10:00:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919706
Page 134 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020
09:36:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919707
Page 135 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020
09:36:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020
09:36:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020
09:36:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-03-2020
09:36:46
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919708
Page 136 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-03-2020
09:36:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020
09:36:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ0X8Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020
09:36:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRJ0X8Initial Entry
5.b
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919709
Page 137 of 195
***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, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-03-2020
09:37:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSMZL
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020
09:37:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSMZL9Initial Entry
5.c
Date Location User Value Reason
Nov-03-2020
09:37:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSMZL
BInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020
09:37:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSMZLBInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919710
Page 138 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919711
Page 139 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919712
Page 140 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919713
Page 141 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MENTAL CONFUSI
ONInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919714
Page 142 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/27/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/27/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 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).
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919715
Page 143 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919716
Page 144 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021
13:48:37ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919717
Page 145 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)LVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021
13:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919718
Page 146 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
14:31:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reiss
ued:OpenedClinical - please
submit ASAP for
data lock; this is
relevant to
calculation of # of
days after last dose
of VAX that SAE
began
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919719
Page 147 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-12-2021
09:54:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
weredACKNOWLEDGED
Mar-10-2021
22:33:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edClinical - Please
submit the VAX4
information
(20Feb21) to the
SAE (#2021253124)
as SAE start date is
after VAX4
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSI
ONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/27/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
13:53:09ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919720
Page 148 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)End Date Time:
Feb/28/2021 UNK:
UNK
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
Mar-09-2021
04:41:56
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Clo
sedResponse satisfies query
Mar-09-2021
04:41:02
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Del
etedClose Auto Query
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919721
Page 149 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time
(US & Canada)
Mar-08-2021
16:23:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ans
weredthis was reported to
Pfizer
Mar-08-2021
04:49:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ope
nedSAE RECON:
HYPERTENSION(Onset
date:27Feb2021) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event on
AE CRF
Mar-04-2021
14:18:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Clo
sedClose Auto Query
Mar-04-2021
14:18:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serio
us event ass
ociated with
congenital a
nomaly or bNew Information
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919722
Page 150 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
irth defect?
NO
Did this seri
ous event re
sult in death
?
NO
Did this seri
ous event re
quire or pro
long hospita
lization?
YES
Did this seri
ous event re
sult in persi
stent or sign
ificant disab
ility/incapac
ity?
NO
Is this serio
us event life
threatening?
NO
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919723
Page 151 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Other medi
cally import
ant serious
event
NO
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ope
nedIs this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please review
and update as
appropriate.
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Can
didateFor AE
HYPERTENSION:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number"
is blank.
Mar-04-2021
13:53:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919724
Page 152 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919725
Page 153 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021
14:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919726
Page 154 of 195
***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, Queries
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-09-2021
04:41:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021253124Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919727
Page 155 of 195
***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
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSIONInitial Entry
4. Start Date Time:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919728
Page 156 of 195
***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
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/28/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919729
Page 157 of 195
***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
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
prevent above outcomes).
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919730
Page 158 of 195
***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
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021
14:20:56ACV0PFEINFP6000 Data Entry:
RECOVERING/RESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919731
Page 159 of 195
***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
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)OLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021
14:20:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919732
Page 160 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919733
Page 161 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919734
Page 162 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FLU ZONE HIGH D
OSE PROPHYLAXI
S INFLUENZA VAC
CINEInitial Entry
5. Date:
Date Location User Value Reason
Nov-06-2020
09:23:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919735
Page 163 of 195
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020
09:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020
09:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020
09:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919736
Page 164 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Transcription
Error
Jan-31-2021
10:21:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919737
Page 165 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-31-2021
10:21:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per other p
rotocol allowance(
s) and confirmed t
o have received on
ly placebo at Vacci
nation 1/2Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919738
Page 166 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-31-2021
10:21:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-31-2021
10:21:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919739
Page 167 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-31-2021
10:21:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919740
Page 168 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-31-2021
10:22:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Jan/30/2021Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919741
Page 169 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-31-2021
10:22:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-31-2021
10:22:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-31-2021
10:22:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919742
Page 170 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919743
Page 171 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919744
Page 172 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-31-2021
10:22:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919745
Page 173 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-31-2021
10:22:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-31-2021
10:22:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-31-2021
10:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-31-2021
10:22:50
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919746
Page 174 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-31-2021
10:22:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/30/2021Initial Entry
5.a
Date Location User Value Reason
Jan-31-2021
10:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPTLX
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-31-2021
10:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPTLX5Initial Entry
5.b
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919747
Page 175 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-31-2021
10:23:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGS99Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-31-2021
10:23:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGS99Initial Entry
5.c
Date Location User Value Reason
Jan-31-2021
10:23:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSGS9
BInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-31-2021
10:23:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGS9BInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919748
Page 176 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-31-2021
10:23:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-31-2021
10:23:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-31-2021
10:23:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-31-2021
10:23:21
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919749
Page 177 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-31-2021
10:23:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/30/2021Initial Entry
5.a
Date Location User Value Reason
Jan-31-2021
10:23:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPTLW
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-31-2021
10:23:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPTLWRInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919750
Page 178 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919751
Page 179 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/30/2021 14:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919752
Page 180 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
8. Actual Dose:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-31-2021
10:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-31-2021
10:23:43ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919753
Page 181 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919754
Page 182 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021
10:20:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919755
Page 183 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919756
Page 184 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919757
Page 185 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-22-2021
10:21:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919758
Page 186 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-22-2021
10:22:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021
10:22:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021
11:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-23-2021
04:53:36
(UTC-06:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919759
Page 187 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-22-2021
10:22:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-22-2021
10:22:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/20/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021
11:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRMM3
BInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919760
Page 188 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-23-2021
11:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRMM3BInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919761
Page 189 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919762
Page 190 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/20/2021 14:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919763
Page 191 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
8. Actual Dose:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-22-2021
10:22:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-22-2021
10:22:21ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919764
Page 192 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919765
Page 193 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-03-2020
09:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-17-2020
10:17:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-17-2020
10:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-03-2020
09:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/2/2020Initial Entry
Sep-17-2020
10:17:46ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919766
Page 194 of 195
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)
Sep-17-2020
10:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919767
Page 195 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
15:34:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f0e\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919768