Document text
Page 1 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977388
Page 2 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977389
Page 3 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091276]
2.Birth Date: 1957
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977390
Page 4 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977391
Page 5 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977392
Page 6 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977393
Page 7 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POSTMENOPAUSAL]
Start Date: Jan/1/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANXIETY]
Start Date: Jan/1/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BREAST CANCER]
Start Date: Jan/1/2012
Ongoing: NO
End Date:
Dec/1/2012
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: Jan/1/2015
Ongoing: YES
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977394
Page 8 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: Jan/1/2005
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: Jan/1/2019
Ongoing: NO
End Date:
Jan/1/2019
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MIGRAINE HEADACHES]
Start Date: Jan/1/1989
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOPOROSIS]
Start Date: Jan/1/2020
Ongoing: YES
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977395
Page 9 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [131.8]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [20.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977396
Page 10 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/21/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977397
Page 11 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [235764]
3.Randomization Group: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977398
Page 12 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
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 [BPXRMT]
5.bSample ID [BPXRMV]
5.cSample ID [BPXRMW]
5.dSample ID [BRWLWN]
5.eSample ID [BRWLWP]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977399
Page 13 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
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 [BPXRS4]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977400
Page 14 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: Aug/21/2020 09:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977401
Page 15 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977402
Page 16 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977403
Page 17 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977404
Page 18 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977405
Page 19 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BPXTPT]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977406
Page 20 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/9/2020 13:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977407
Page 21 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977408
Page 22 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BR84NV]
5.bSample ID [BSGWJX]
5.cSample ID [BSGWJY]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977409
Page 23 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977410
Page 24 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977411
Page 25 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977412
Page 26 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977413
Page 27 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977414
Page 28 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977415
Page 29 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977416
Page 30 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977417
Page 31 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977418
Page 32 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977419
Page 33 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977420
Page 34 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977421
Page 35 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977422
Page 36 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977423
Page 37 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Acute appendicitis wit
h necrosis Sep/30/2020
23:00 NO
End Date Time:
Oct/2/2020 11:00
Repeating
Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977424
Page 38 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Acute appendicitis with necrosis]
4.Start Date Time: Sep/30/2020 23:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 11:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
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
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977425
Page 39 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
[Infection of appendix]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020399436]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977426
Page 40 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977427
Page 41 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977428
Page 42 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977429
Page 43 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977430
Page 44 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977431
Page 45 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977432
Page 46 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977433
Page 47 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977434
Page 48 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977435
Page 49 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977436
Page 50 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977437
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977438
Page 52 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977439
Page 53 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977440
Page 54 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977441
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977442
Page 56 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977443
Page 57 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977444
Page 58 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/23/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977445
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977446
Page 60 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977447
Page 61 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/27/2021
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977448
Page 62 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/27/2021
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977449
Page 63 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977450
Page 64 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977451
Page 65 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977452
Page 66 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/27/2021
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 [BRF6C9]
5.bSample ID [BS9XGW]
5.cSample ID [BS9XGX]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977453
Page 67 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/27/2021
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 [BRF6CY]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977454
Page 68 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/27/2021 13:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977455
Page 69 of 165
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977456
Page 70 of 165
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977457
Page 71 of 165
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977458
Page 72 of 165
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977459
Page 73 of 165
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977460
Page 74 of 165
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977461
Page 75 of 165
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977462
Page 76 of 165
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977463
Page 77 of 165
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977464
Page 78 of 165
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977465
Page 79 of 165
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977466
Page 80 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977467
Page 81 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977468
Page 82 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin Approved Mar-10-2021 14:39:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977469
Page 83 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-21-2020 10:23:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977470
Page 84 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-27-2021 14:23:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977471
Page 85 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977472
Page 86 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977473
Page 87 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977474
Page 88 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977475
Page 89 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977476
Page 90 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977477
Page 91 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977478
Page 92 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977479
Page 93 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-27-2021 14:24:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977480
Page 94 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin Approved Mar-10-2021 14:39:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-23-2021 16:45:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Oct-29-2020 09:07:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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 Oct-28-2020 10:18:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977481
Page 95 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Bruce Rankin Approved Oct-21-2020 15:26:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977482
Page 96 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020 10:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020 10:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977483
Page 97 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020 10:21:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/21/2020Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977484
Page 98 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-15-2020
08:12:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Appendicitis SAE added in
AE CRF
Oct-15-2020
08:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Oct-15-2020
06:33:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020399436
Appendicitis from an
Infection(onset
date:30SEP2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-21-2020
10:21:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11091276Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 10:21:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
3. Sex:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977485
Page 99 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 10:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020 10:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 10:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977486
Page 100 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020 10:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977487
Page 101 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 10:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 10:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 10:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977488
Page 102 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 10:43:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:POSTMENOP
AUSAL
Start Date: Jan/1/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:43:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:43:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSTMENOPAUSALInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020 10:43:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020 10:43:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977489
Page 103 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b
Date Location User Value Reason
Aug-21-2020 10:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:ANXIET
Y
Start Date: Jan/1/201
5
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:43:43
(UTC-05:00) Eastern
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
Aug-21-2020 10:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ANXIETYInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020 10:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020 10:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977490
Page 104 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-21-2020 10:44:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:BREAST CA
NCER
Start Date: Jan/1/2012
Ongoing: NO
End Date:
Dec/1/2012Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977491
Page 105 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:44:15
(UTC-05:00) Eastern
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
Aug-21-2020 10:44:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BREAST CANCERInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-21-2020 10:44:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-21-2020 10:44:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/1/2012Initial Entry
1.d
Date Location User Value Reason
Aug-21-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:DEPRESSI
ON
Start Date: Jan/1/2015
Ongoing: YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977492
Page 106 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEPRESSIONInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-21-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-21-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-21-2020 10:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:HYPERCHOLES
TEROLEMIA
Start Date: Jan/1/2005
Ongoing: YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977493
Page 107 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERCHOLESTEROLEMI
AInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-21-2020 10:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-21-2020 10:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-21-2020 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:HYSTERECT
OMY
Start Date: Jan/1/2019Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977494
Page 108 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing: NO
End Date:
Jan/1/2019
1.f Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYSTERECTOMYInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-21-2020 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-21-2020 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/1/2019Initial Entry
1.g
Date Location User Value Reason
Aug-21-2020 10:50:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977495
Page 109 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Medical Histo
ry Term:MIGRAINE HE
ADACHES
Start Date: Jan/1/1989
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:50:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:50:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MIGRAINE HEADACHESInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-21-2020 10:50:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1989Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-21-2020 10:50:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-21-2020 10:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977496
Page 110 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Medical History
Term:OSTEOPOR
OSIS
Start Date: Jan/1/2020
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-21-2020 10:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 10:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OSTEOPOROSISInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-21-2020 10:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-21-2020 10:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977497
Page 111 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
131.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977498
Page 112 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.0Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.8
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977499
Page 113 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 10:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977500
Page 114 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977501
Page 115 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-21-2020 10:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977502
Page 116 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 11:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 11:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
235764Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977503
Page 117 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 11:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 11:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 11:46:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 11:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu
R Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-21-2020 11:00:47
(UTC-05:00) Eastern
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.
Aug-21-2020 11:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977504
Page 118 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug/21/2020
5.a
Date Location User Value Reason
Aug-21-2020 11:46:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXRMTInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 11:46:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXRMTInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 11:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXRMVInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 11:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXRMVInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXRMWInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977505
Page 119 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXRMWInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRWLWNInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRWLWNInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020 11:49:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRWLWPTranscription Error
Aug-21-2020 11:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRWLWPJInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977506
Page 120 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 11:49:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 11:49:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRWLWPTranscription Error
Aug-21-2020 11:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in
length. Please
review and correct
as appropriate.
Aug-21-2020 11:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRWLWPJInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977507
Page 121 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 10:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 10:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 10:53:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 10:53:28
(UTC-05:00) Eastern
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.
Aug-21-2020 10:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977508
Page 122 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 10:53:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXRS4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 10:53:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXRS4Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977509
Page 123 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020 09:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977510
Page 124 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-21-2020 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977511
Page 125 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020 03:30:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 14:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Sep-04-2020 14:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTChanged Information
Sep-03-2020 11:52:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-21-2020 11:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977512
Page 126 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 16:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977513
Page 127 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.5
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977514
Page 128 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 16:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977515
Page 129 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977516
Page 130 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-09-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977517
Page 131 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 16:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 16:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 03:20:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Sep-09-2020 16:07:14
(UTC-05:00) Eastern
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.
Sep-09-2020 16:07:14
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977518
Page 132 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) Date of Collection:
Sep/9/2020
5.a
Date Location User Value Reason
Sep-10-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXTPTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXTPTInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977519
Page 133 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 13:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977520
Page 134 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-09-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0977521
Page 135 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 14:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977522
Page 136 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 14:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 14:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 16:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 14:48:46
(UTC-05:00) Eastern
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.
Oct-14-2020 14:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977523
Page 137 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-14-2020 16:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR84NVInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 16:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR84NVInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 06:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGWJXInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 06:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSGWJXInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 06:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGWJYInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 06:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSGWJYInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977524
Page 138 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020 14:49:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 14:49:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 14:49:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977525
Page 139 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977526
Page 140 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
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
Oct-29-2020
05:18:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-28-2020
10:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-28-2020
10:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute appendicitis with n
ecrosisChanged Information
Oct-28-2020
09:34:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020399436,
the term in Safety database
was updated to 'acute
appendicitis with necrosis'.
Please confirm if the event
term is the same as
"Necrotizing appendicitis".
If so, please consider
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977527
Page 141 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
updating event term on CRF
for coding purpose.
Oct-15-2020
07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 23:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 11:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:01:39
(UTC-05:00) EasternACV0PFEINFP6000 Query 3: Closed Query closed; will
follow for SAE
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977528
Page 142 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) update with
requested COVID
test info
Oct-28-2020 10:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Sent fax with SAE
follow up
Oct-27-2020 21:09:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - please
send SAE safety
followup with the
DATE of COVID
test during
hospitalization
(from 9/30 -
10/2/20)
Oct-15-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-15-2020 08:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-15-2020 08:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization
?
YES
Did this serious event result
in persistent or significant dTranscription Error
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977529
Page 143 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
isability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
NO
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE
Appendicitis :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Is the adverse
event serious?' is
marked as YES,
but responses to all
of the seriousness
criteria are NO. At
least one
seriousness
criterion is
expected to be YES
for serious events.
Please review and
update as
appropriate.
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NOInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977530
Page 144 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization
?
NO
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious 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.
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020
17:27:05
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query
2: Clos
edResponse
satisfies query
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977531
Page 145 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US &
Canada)
Oct-29-2020
08:53:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredPlease advise
what page
Oct-29-2020
08:44:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Ope
nedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in the
comment field
[Infection].
Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary.
Oct-26-2020
21:42:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edQuery closed;
will follow for
SAE update
with requested
COVID test
info
Oct-24-2020
15:04:09
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
weredUpdate sent
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0977532
Page 146 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Oct-22-2020
23:06:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ope
nedClinical -
COVID testing
has not been
reported in the
SAE submitted
to safety.
Please submit
a follow-up
SAE form
[#2020399436]
to provide
whether
COVID testing
was performed
(yes/no) and if
yes, the results.
Oct-15-2020
07:38:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relat
ed to
study
treat
ment(
s), thi
s even
t is du
e to:
OT
HE
R
If
Ot
her
, s
pe
cifInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977533
Page 147 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
y:
I
n
f
e
c
ti
o
n
o
f
a
p
p
e
n
d
i
x
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977534
Page 148 of 165
***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, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-15-2020 07:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-15-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020399436Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977535
Page 149 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 16:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977536
Page 150 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021 16:45:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977537
Page 151 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021 16:45:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-23-2021 16:45:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977538
Page 152 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-27-2021 14:22:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/27/2021Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977539
Page 153 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-27-2021 14:23:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Feb/27/2021Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977540
Page 154 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-27-2021 14:23:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-27-2021 14:23:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-27-2021 14:23:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977541
Page 155 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977542
Page 156 of 165
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-27-2021 14:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977543
Page 157 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021 14:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021 14:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 06:52:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 06:10:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-27-2021 14:25:06
(UTC-05:00) Eastern
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-27-2021 14:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977544
Page 158 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb/27/2021
5.a
Date Location User Value Reason
Mar-02-2021 06:52:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF6C9Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 06:52:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF6C9Initial Entry
5.b
Date Location User Value Reason
Mar-02-2021 06:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS9XGWInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021 06:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS9XGWInitial Entry
5.c
Date Location User Value Reason
Mar-02-2021 06:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS9XGXInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0977545
Page 159 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Mar-02-2021 06:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS9XGXInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977546
Page 160 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021 14:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021 14:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 06:53:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 06:10:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-27-2021 14:25:18
(UTC-05:00) Eastern
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-27-2021 14:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977547
Page 161 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb/27/2021
5.a
Date Location User Value Reason
Mar-02-2021 06:53:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF6CYInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 06:53:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF6CYInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977548
Page 162 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/27/2021 13:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977549
Page 163 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-27-2021 14:26:05
(UTC-05:00) Eastern
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-27-2021 14:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977550
Page 164 of 165
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020 14:49:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020 11:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 10:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020 14:49:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-21-2020 11:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
Aug-21-2020 10:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977551
Page 165 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091276 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 15:25:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ee0\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977552