Document text
Page 1 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964082
Page 2 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964083
Page 3 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10871191]
2.Birth Date: /1968
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964084
Page 4 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964085
Page 5 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964086
Page 6 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964087
Page 7 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Alopecia]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964088
Page 8 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [73.0]
3.Unit: kg
4.Height: [170.2]
5.Unit: cm
6.Body Mass Index: [25.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964089
Page 9 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [65289]
3.Randomization Group: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964090
Page 10 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BP9ZK1]
5.bSample ID [BP9ZK2]
5.cSample ID [BP9ZK3]
5.dSample ID [BPHB7X]
5.eSample ID [BPHB7Y]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964091
Page 11 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BP8BGL]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964092
Page 12 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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/25/2020 10:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964093
Page 13 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964094
Page 14 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964095
Page 15 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964096
Page 16 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BP8B23]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964097
Page 17 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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/15/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964098
Page 18 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964099
Page 19 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BR250T]
5.bSample ID [BSJ1ZV]
5.cSample ID [BSJ1Y6]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964100
Page 20 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964101
Page 21 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964102
Page 22 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964103
Page 23 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964104
Page 24 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964105
Page 25 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964106
Page 26 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964107
Page 27 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964108
Page 28 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964109
Page 29 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964110
Page 30 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964111
Page 31 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964112
Page 32 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964113
Page 33 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964114
Page 34 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 Fever Mar/1/20
21 19:00 NO
End Date Time:
Mar/1/2021 23:0
0
Repeating
Pages
2.ADVERS
E EVENT
2 Swollen Lymph Nodes
- Left Axillary Region
Mar/2/20
21 07:00 YES Repeating
Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964115
Page 35 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[Fever]
4.Start Date Time: Mar/1/2021 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/1/2021 23:00
6.Toxicity Grade: 2
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964116
Page 36 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964117
Page 37 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964118
Page 38 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Swollen Lymph Nodes - Left Axillary Region]
4.Start Date Time: Mar/2/2021 07:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964119
Page 39 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964120
Page 40 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964121
Page 41 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964122
Page 42 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964123
Page 43 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964124
Page 44 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964125
Page 45 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964126
Page 46 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964127
Page 47 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964128
Page 48 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964129
Page 49 of 163
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964130
Page 50 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964131
Page 51 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964132
Page 52 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964133
Page 53 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964134
Page 54 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964135
Page 55 of 163
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964136
Page 56 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964137
Page 57 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964138
Page 58 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964139
Page 59 of 163
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964140
Page 60 of 163
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964141
Page 61 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964142
Page 62 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964143
Page 63 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964144
Page 64 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/8/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964145
Page 65 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BR8YMH]
5.bSample ID [BMP0VV]
5.cSample ID [BMP0R4]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964146
Page 66 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BR8YN0]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964147
Page 67 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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/8/2021 09:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964148
Page 68 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964149
Page 69 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BMBBFZ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964150
Page 70 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: Mar/1/2021 10:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964151
Page 71 of 163
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964152
Page 72 of 163
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964153
Page 73 of 163
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964154
Page 74 of 163
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964155
Page 75 of 163
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964156
Page 76 of 163
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964157
Page 77 of 163
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964158
Page 78 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964159
Page 79 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964160
Page 80 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin
Cannon Approved Mar-05-2021 13:00:59 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964161
Page 81 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-25-2020 15:03:38 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964162
Page 82 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-12-2021 12:13:06
(UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964163
Page 83 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin
Cannon Approved Mar-05-2021 13:00:59
(UTC-05:00) Eastern Time (US &
Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-04-2021 14:34:08
(UTC-05:00) Eastern Time (US &
Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin
Cannon Approved Mar-03-2021 17:11:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964164
Page 84 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-10-2021 11:47:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin
Cannon Approved Oct-21-2020 19:09:04 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964165
Page 85 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020
15:02:45
(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-25-2020
15:02:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964166
Page 86 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020
15:02:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/25/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964167
Page 87 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020
15:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10871191Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
15:02:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1968Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
15:03:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964168
Page 88 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
15:03:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
15:03:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964169
Page 89 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020
15:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964170
Page 90 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020
15:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
15:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
15:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964171
Page 91 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Alopecia
Start Date: UNK/U
NK/199
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:07:45
(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-25-2020
15:07:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
AlopeciaInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964172
Page 92 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-25-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964173
Page 93 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
73.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964174
Page 94 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
170.2Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.2Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964175
Page 95 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964176
Page 96 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
15:05:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964177
Page 97 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020
15:06:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
15:06:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
65289Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964178
Page 98 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
15:05:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
15:05:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
20:41:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
15:05:34
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964179
Page 99 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:05:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
20:41:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BP9Z
K1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
20:41:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9ZK1Initial Entry
5.b
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964180
Page 100 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
20:41:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BP9Z
K2Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
20:41:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9ZK2Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020
20:41:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BP9Z
K3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
20:41:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9ZK3Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964181
Page 101 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d
Date Location User Value Reason
Aug-25-2020
21:19:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BPHB
7XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020
21:19:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPHB7XInitial Entry
5.e
Date Location User Value Reason
Aug-25-2020
21:19:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BPHB
7YInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964182
Page 102 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.e Sample ID
Date Location User Value Reason
Aug-25-2020
21:19:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPHB7YInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964183
Page 103 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
15:05:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
15:05:45
(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-25-2020
21:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
15:05:45
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964184
Page 104 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:05:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
21:31:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BP8B
GLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
21:31:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8BGLInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964185
Page 105 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964186
Page 106 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 10:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964187
Page 107 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-25-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964188
Page 108 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020
15:07:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENIC
ITY E-DIARY NOT C
OLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964189
Page 109 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
11:08:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964190
Page 110 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964191
Page 111 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
11:08:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964192
Page 112 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
11:08:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
11:08:39
(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-18-2020
17:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
11:08:39
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964193
Page 113 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
11:08:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
17:44:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP8B
23Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
17:44:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8B23Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964194
Page 114 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964195
Page 115 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 09:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964196
Page 116 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-18-2020
11:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964197
Page 117 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
09:33:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964198
Page 118 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
09:33:26
(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
09:33:26
(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
12:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-14-2020
10:32:18
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opene
d'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964199
Page 119 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
09:33:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
09:33:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collec
tion:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
12:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR25
0TInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964200
Page 120 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-14-2020
12:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR250TInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020
12:29:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJ1Z
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
12:29:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSJ1ZVInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
12:30:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJ1
Y6Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964201
Page 121 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
12:30:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSJ1Y6Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964202
Page 122 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
09:33:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
09:33:39
(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
09:33:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964203
Page 123 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964204
Page 124 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964205
Page 125 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021
14:34:08
(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
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964206
Page 126 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Mar/1/2021 23:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964207
Page 127 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021
14:34:08
(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
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021
14:34:23
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964208
Page 128 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964209
Page 129 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-04-2021
14:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964210
Page 130 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Swollen Lymph Nodes
- Left Axillary RegionInitial Entry
4. Start Date Time:
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964211
Page 131 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964212
Page 132 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
prevent above outcomes).
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021
14:36:17
(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
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964213
Page 133 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021
14:36:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964214
Page 134 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021
14:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964215
Page 135 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
11:47:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964216
Page 136 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021
12:12:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Close
dClose Auto
Query
Feb-11-2021
02:07:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-10-2021
11:48:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cand
idateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964217
Page 137 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
complete this
date.
Feb-10-2021
11:48:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is
willing to retur
n for Vaccinati
on 3
Participant is:
eligible per
other protoc
ol allowanc
e(s) and con
firmed to ha
ve received
only placeb
o at Vaccina
tion 1/2Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964218
Page 138 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021
18:53:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Close
dClose Auto
Query
Feb-15-2021
18:53:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Transcription
Error
Feb-12-2021
12:12:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opene
dResponse to
"Date
Treatment
Unblinded"
17/Feb/2021 is
a future date
relative to
when it was
entered on
12/Feb/2021.
Please correct.
Feb-12-2021
12:12:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964219
Page 139 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
12:12:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIB
ILITY FOR ADD
ITIONAL VACC
INATIONInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964220
Page 140 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021
15:54:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies
query
Feb-12-2021
12:13:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1: A
nsweredUpdated
Feb-11-2021
07:36:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1: O
penedDM: Kindly review
and complete
‘Vaccination,
Informed Consent
and
Inclusion/Exclusion
Criteria form' at
this visit. Thank
you.
Feb-10-2021
11:48:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entry
:
Feb/8/2021Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964221
Page 141 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021
12:12:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Feb/8/2021Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964222
Page 142 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-10-2021
11:49:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-10-2021
11:49:03
(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-10-2021
11:49:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964223
Page 143 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
11:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
11:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
11:49:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Feb-10-2021
11:49:15
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964224
Page 144 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-10-2021
11:49:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collec
tion:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
11:49:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BR8Y
MHInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
11:49:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8YMHInitial Entry
5.b
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964225
Page 145 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Feb-10-2021
11:49:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BMP0
VVInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-10-2021
11:49:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BMP0VVInitial Entry
5.c
Date Location User Value Reason
Feb-10-2021
11:49:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BMP0
R4Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964226
Page 146 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Feb-10-2021
11:49:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BMP0R4Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964227
Page 147 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
11:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
11:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
11:50:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Feb-10-2021
11:50:08
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964228
Page 148 of 163
***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, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-10-2021
11:50:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collec
tion:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
11:50:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample
ID:BR8Y
N0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
11:50:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR8YN0Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964229
Page 149 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964230
Page 150 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 09:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964231
Page 151 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
8. Actual Dose:
Date Location User Value Reason
Feb-12-2021
12:13:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-12-2021
12:13:41
(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-12-2021
12:13:41
(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-12-2021
12:13:41ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964232
Page 152 of 163
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time
(US & Canada)
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964233
Page 153 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
16:34:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964234
Page 154 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
16:34:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
16:34:38
(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
17:37:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-02-2021
04:53:41
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964235
Page 155 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
16:34:38
(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.
Mar-01-2021
16:34:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021
17:37:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BMBBF
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964236
Page 156 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Mar-02-2021
17:37:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BMBBFZInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964237
Page 157 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964238
Page 158 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021 10:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0964239
Page 159 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
8. Actual Dose:
Date Location User Value Reason
Mar-01-2021
16:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-01-2021
16:34:59
(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
Mar-01-2021
16:34:59
(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
Mar-01-2021
16:34:59ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0964240
Page 160 of 163
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0964241
Page 161 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
09:33:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020
15:06:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-25-2020
15:03:57
(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
09:33:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-25-2020
15:06:23ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964242
Page 162 of 163
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-25-2020
15:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0964243
Page 163 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
19:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kevin
CannonData Entry:
Click Here to EnableInitial Entry
090177e196ae4038\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0964244