Document text
Page 1 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968038
Page 2 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968039
Page 3 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10891181]
2.Birth Date: 1998
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968040
Page 4 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968041
Page 5 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968042
Page 6 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968043
Page 7 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:[right shoulder injury]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right shoulder surgery]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968044
Page 8 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [149.4]
3.Unit: LB
4.Height: [69.2]
5.Unit: in
6.Body Mass Index: [21.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968045
Page 9 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [65230]
3.Randomization Group: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968046
Page 10 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [BPYHHZ]
5.bSample ID [BPYHJ0]
5.cSample ID [BPYHJ1]
5.dSample ID [BNW63G]
5.eSample ID [BNW63H]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968047
Page 11 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [BP3PMS]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968048
Page 12 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 12:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968049
Page 13 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968050
Page 14 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968051
Page 15 of 139
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [98.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968052
Page 16 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [BP9RWB]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968053
Page 17 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 14:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968054
Page 18 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968055
Page 19 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [BPYH8L]
5.bSample ID [BSJMT8]
5.cSample ID [BSJMT9]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968056
Page 20 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968057
Page 21 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
Mar/10/2021
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 [BSJLZL]
5.bSample ID [BSJLZK]
5.cSample ID [BP9S50]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968058
Page 22 of 139
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968059
Page 23 of 139
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968060
Page 24 of 139
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968061
Page 25 of 139
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968062
Page 26 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968063
Page 27 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968064
Page 28 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968065
Page 29 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968066
Page 30 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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?
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968067
Page 31 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968068
Page 32 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968069
Page 33 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968070
Page 34 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968071
Page 35 of 139
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968072
Page 36 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968073
Page 37 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968074
Page 38 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968075
Page 39 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968076
Page 40 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Exposure During P
artner Pregnancy Dec/25/2020
UNK:UNK YES Repeating
Pages
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968077
Page 41 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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)[Exposure During Partner Pregnancy]
4.Start Date Time: Dec/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968078
Page 42 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[unsafe sexual intercourse]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968079
Page 43 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
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[ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968080
Page 44 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968081
Page 45 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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[ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968082
Page 46 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968083
Page 47 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: //
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968084
Page 48 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968085
Page 49 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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?
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968086
Page 50 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968087
Page 51 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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?
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968088
Page 52 of 139
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968089
Page 53 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968090
Page 54 of 139
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968091
Page 55 of 139
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968092
Page 56 of 139
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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?
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968093
Page 57 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968094
Page 58 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968095
Page 59 of 139
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968096
Page 60 of 139
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968097
Page 61 of 139
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968098
Page 62 of 139
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968099
Page 63 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968100
Page 64 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968101
Page 65 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968102
Page 66 of 139
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968103
Page 67 of 139
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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: [ ]
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968104
Page 68 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968105
Page 69 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968106
Page 70 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
Cecil
Farrington Approved Mar-12-2021 12:40:15 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, 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.
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968107
Page 71 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-25-2020 13:28:45
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968108
Page 72 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-25-2021 07:46:52 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968109
Page 73 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
Cecil
Farrington Approved Mar-12-2021 12:40:15 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, 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-11-2021 14:36:30 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Mar-10-2021 16:11:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968110
Page 74 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, CecilFarrington, 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-10-2021 13:43:39 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Mar-02-2021 23:36:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, 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.
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968111
Page 75 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
N/A Feb-25-2021 07:46:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Feb-23-2021 23:10:53 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, 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-19-2021 13:48:23 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Oct-20-2020 15:32:10 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968112
Page 76 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, CecilFarrington, 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.
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968113
Page 77 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:27:55
(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
13:27:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968114
Page 78 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/25/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968115
Page 79 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:27:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10891181Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
13:27:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1998Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
13:28:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968116
Page 80 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
13:28:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
13:28:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968117
Page 81 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:28:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968118
Page 82 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:28:57
(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
13:28:57
(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
13:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968119
Page 83 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
15:27:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:right shoul
der injury
Start Date
:UNK/UN
K/2014
Ongoing: NO
End Date
:
UNK/U
NK/201
4Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:27:32
(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:
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968120
Page 84 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-25-2020
15:27:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right shoulder injuryInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020
15:27:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
15:27:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.b
Date Location User Value Reason
Aug-25-2020
15:27:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968121
Page 85 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada) Medical
History T
erm:right shoul
der surgery
Start Dat
e:UNK/UNK
/2014
Ongoing: NO
End Date:
UNK/U
NK/201
4
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968122
Page 86 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:27:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
15:27:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right shoulder surge
ryInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020
15:27:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020
15:27:51ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968123
Page 87 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2014
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968124
Page 88 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
149.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968125
Page 89 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.2Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21.9Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968126
Page 90 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEA
D
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968127
Page 91 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
15:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968128
Page 92 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:33
(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
13:29:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
65230Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968129
Page 93 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:19
(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
13:29:19
(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
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
13:29:19
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968130
Page 94 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPYHH
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYHHZInitial Entry
5.b
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968131
Page 95 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-25-2020
17:10:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPYHJ
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
17:10:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYHJ0Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020
17:10:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPYHJ
1Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0968132
Page 96 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
17:10:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYHJ1Initial Entry
5.d
Date Location User Value Reason
Aug-25-2020
17:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNW63
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020
17:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW63GInitial Entry
5.e
Date Location User Value Reason
Aug-25-2020
17:10:58ACV0PFEINFP6000 Data Entry:
Sample I BNW63Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968133
Page 97 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)D: H
5.e Sample ID
Date Location User Value Reason
Aug-25-2020
17:10:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW63HInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968134
Page 98 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:13
(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
13:29:13
(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
17:11:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
13:29:13
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968135
Page 99 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
17:11:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3PM
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
17:11:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3PMSInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968136
Page 100 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
15:28:09
(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
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968137
Page 101 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-25-2020
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 12:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
15:28:09
(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
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968138
Page 102 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
15:28:09
(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
15:28:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968139
Page 103 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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
13:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTED
FOR THIS SUBJEC
TInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968140
Page 104 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-15-2020
14:55:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968141
Page 105 of 139
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.5
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968142
Page 106 of 139
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
14:56:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968143
Page 107 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020
14:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020
14:56:21
(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-15-2020
16:21:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-15-2020
14:56:21
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968144
Page 108 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-15-2020
14:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020
16:21:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP9RW
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020
16:21:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RWBInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968145
Page 109 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968146
Page 110 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 14:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020
14:56:43
(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-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968147
Page 111 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020
14:56:43
(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-15-2020
14:56:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968148
Page 112 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-13-2020
15:59:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968149
Page 113 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
15:59:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
15:59:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
15:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
15:59:10
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968150
Page 114 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-13-2020
15:59:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
15:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPYH8
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
15:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYH8LInitial Entry
5.b
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968151
Page 115 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-13-2020
16:09:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJMT
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020
16:09:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJMT8Initial Entry
5.c
Date Location User Value Reason
Oct-13-2020
16:09:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJMT
9Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968152
Page 116 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Oct-13-2020
16:09:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJMT9Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968153
Page 117 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-10-2021
13:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/10/2021Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968154
Page 118 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021
13:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021
13:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
15:55:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
13:43:50
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968155
Page 119 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-10-2021
13:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021
14:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJLZ
LTranscription
Error
Mar-10-2021
15:55:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJL
ZJInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021
14:36:30
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
BSJLZLTranscription
Error
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0968156
Page 120 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
Mar-10-2021
15:55:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJLZJInitial Entry
5.b
Date Location User Value Reason
Mar-10-2021
15:55:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSJLZ
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
15:55:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJLZKInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
15:55:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Sample ID
:BP9S5
0Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968157
Page 121 of 139
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
15:55:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9S50Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968158
Page 122 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-13-2020
15:59:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
15:59:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020
15:59:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968159
Page 123 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968160
Page 124 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021
13:48:23
(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-02-2021
12:52:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Mar-02-2021
12:51:53
(UTC-05:00)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968161
Page 125 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)
Feb-26-2021
13:04:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dthis has all
been updated
and sent in on
25FEB2021
Feb-26-2021
13:03:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answere
dthis has all
been updated
and sent in on
25FEB2021
Feb-26-2021
00:24:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:
OpenedClinical Please
submit a PG
safety update
to complete
Partner info:
contraception
method,
non-smoker
and her use of
any medication
Feb-26-2021
00:24:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Event
term is
Exposure
during
Pregnancy;
however, PG
safety report
event term is
'Pregnancy'.
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968162
Page 126 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Please submit a
PG safety
followup to
update the
event term to
'Exposure
during
Pregnancy'
Feb-26-2021
00:19:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-25-2021
11:19:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answere
dChanged
Information
Feb-25-2021
11:19:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged
Information
Feb-25-2021
11:19:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Exposure During P
artner PregnancyChanged
Information
Feb-24-2021
10:39:03
(UTC-05:00)ACV0PFEINFP6000 Query 2: Opened Clinical Please
submit a PG
safety update
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968163
Page 127 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)to complete
Partner info:
contraception
method,
non-smoker
and her use of
any medication
Feb-24-2021
10:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical As per
CRF CG
8.50.2.5, a
healthy
pregnancy is
not an AE
term; instead
“Exposure
During Partner
Pregnancy”
will be
recorded as an
AE in the CRF
until 6 months
after the last
dose of study
intervention.
Please update
PG safety
report also
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
pregnant partnerInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968164
Page 128 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4. Start Date Time:
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/25/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021
00:18:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-25-2021
07:46:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968165
Page 129 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-25-2021
07:46:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription
Error
Feb-25-2021
07:46:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Feb-24-2021
10:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical As per
CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During Partner
Pregnancy” is
reported as Not
Applicable
Feb-19-2021
13:48:23
(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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968166
Page 130 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
prevent above outcomes).
Date Location User Value Reason
Feb-19-2021
13:48:23
(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
Feb-19-2021
13:48:23
(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
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
unsafe sexual inInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968167
Page 131 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
tercourse
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-19-2021
13:48:23
(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
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968168
Page 132 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-19-2021
13:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968169
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***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-19-2021
14:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968170
Page 134 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-19-2021
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
14:45:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-19-2021
14:45:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NOT
confirmed to hav
e received only p
lacebo at VaccinaInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968171
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***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
tion 1/2
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968172
Page 136 of 139
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 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-19-2021
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-19-2021
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968173
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***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020
15:59:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020
13:29:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-25-2020
13:28:57
(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-13-2020
15:59:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-25-2020
13:29:33ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968174
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***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-25-2020
13:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968175
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***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020
15:06:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2f30\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968176