Document text
Page 1 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955041
Page 2 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955042
Page 3 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10791183]
2.Birth Date: /1963
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:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955043
Page 4 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955044
Page 5 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955045
Page 6 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955046
Page 7 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955047
Page 8 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955048
Page 9 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [240094]
3.Randomization Group: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955049
Page 10 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BMPYNM]
5.bSample ID [BMPYNN]
5.cSample ID [BPXVK6]
5.dSample ID [BPXVK7]
5.eSample ID [BPXVK8]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955050
Page 11 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPXVJF]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955051
Page 12 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 10:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955052
Page 13 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955053
Page 14 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955054
Page 15 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955055
Page 16 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3Z9]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955056
Page 17 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 09:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955057
Page 18 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955058
Page 19 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BSH8KP]
5.bSample ID [BLG10W]
5.cSample ID [BPB0RV]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955059
Page 20 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955060
Page 21 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955061
Page 22 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955062
Page 23 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955063
Page 24 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955064
Page 25 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955065
Page 26 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955066
Page 27 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955067
Page 28 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955068
Page 29 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955069
Page 30 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955070
Page 31 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955071
Page 32 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955072
Page 33 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955073
Page 34 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955074
Page 35 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955075
Page 36 of 128
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955076
Page 37 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955077
Page 38 of 128
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955078
Page 39 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955079
Page 40 of 128
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955080
Page 41 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955081
Page 42 of 128
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955082
Page 43 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955083
Page 44 of 128
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955084
Page 45 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955085
Page 46 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955086
Page 47 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955087
Page 48 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955088
Page 49 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955089
Page 50 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955090
Page 51 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955091
Page 52 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955092
Page 53 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955093
Page 54 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955094
Page 55 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955095
Page 56 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955096
Page 57 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955097
Page 58 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955098
Page 59 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955099
Page 60 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRN1J9]
5.bSample ID [BS238N]
5.cSample ID [BS237J]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955100
Page 61 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRN1H2]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955101
Page 62 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 09:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955102
Page 63 of 128
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955103
Page 64 of 128
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955104
Page 65 of 128
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955105
Page 66 of 128
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955106
Page 67 of 128
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955107
Page 68 of 128
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955108
Page 69 of 128
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955109
Page 70 of 128
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955110
Page 71 of 128
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955111
Page 72 of 128
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955112
Page 73 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955113
Page 74 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955114
Page 75 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad Approved Mar-10-2021 19:30:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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.
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955115
Page 76 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-26-2020 21:37:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955116
Page 77 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-26-2020 21:38:28 (UTC-05:00) Eastern
Time (US & Canada)Subject did not report any significant medical
history or surgeries.
Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955117
Page 78 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-24-2021 16:16:13 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955118
Page 79 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Feb-24-2021 16:16:13 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955119
Page 80 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-24-2021 16:16:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955120
Page 81 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Feb-24-2021 16:16:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955121
Page 82 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-08-2021 11:40:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955122
Page 83 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad Approved Mar-10-2021 19:30:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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-24-2021 16:14:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad Approved Oct-27-2020 15:34:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-27-2020 15:14:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955123
Page 84 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
George Raad Approved Oct-21-2020 13:59:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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.
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955124
Page 85 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020 21:36:25
(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-26-2020 21:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955125
Page 86 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 21:36:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/26/2020Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955126
Page 87 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 21:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10791183Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 21:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 21:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 21:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 21:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMER
ICANInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955127
Page 88 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 21:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955128
Page 89 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020 21:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 21:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 21:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955129
Page 90 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.4Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955130
Page 91 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 21:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955131
Page 92 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 21:39:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 21:39:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
240094Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955132
Page 93 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 21:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 21:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 00:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 06:40:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 21:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 21:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955133
Page 94 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-28-2020 00:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMPYNMInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 00:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMPYNMInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 00:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMPYNNInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 00:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMPYNNInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 00:24:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXVK6Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 00:24:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXVK6Initial Entry
5.d
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955134
Page 95 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-28-2020 00:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXVK7Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 00:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXVK7Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020 00:25:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXVK8Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 00:25:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXVK8Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955135
Page 96 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 21:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 21:40:19
(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-26-2020 21:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 21:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 21:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 21:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXVJFInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955136
Page 97 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 21:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXVJFInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955137
Page 98 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 10:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 21:41:16
(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-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955138
Page 99 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-26-2020 21:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955139
Page 100 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-26-2020 21:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955140
Page 101 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020 16:30:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955141
Page 102 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.5
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955142
Page 103 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020 16:30:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955143
Page 104 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 16:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 16:31:00
(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-19-2020 16:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-19-2020 16:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-19-2020 16:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020 16:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY3Z9Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955144
Page 105 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-19-2020 16:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY3Z9Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955145
Page 106 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 09:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 16:31:30
(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-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955146
Page 107 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-19-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955147
Page 108 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020 15:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955148
Page 109 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 15:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 15:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSH8KPInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955149
Page 110 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 15:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSH8KPInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 15:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG10WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 15:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLG10WInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 15:15:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPB0RVInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 15:15:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPB0RVInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955150
Page 111 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020 15:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 15:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 15:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955151
Page 112 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 16:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955152
Page 113 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 11:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per other protocol a
llowance(s) and confirmed
to have received only place
bo at Vaccination 1/2Transcription Error
Feb-24-2021 16:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 16:14:58
(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-24-2021 16:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955153
Page 114 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-25-2021
13:36:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
seddata updated
Feb-25-2021
10:46:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-25-2021
10:46:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1
7/202
1Transcription Error
Feb-25-2021
06:07:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7450599;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-24-2021
16:15:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1
1/202
1Initial Entry
2. Primary Reason for Unblinding:
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955154
Page 115 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-24-2021 16:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955155
Page 116 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-24-2021 16:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955156
Page 117 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-24-2021 16:16:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955157
Page 118 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 11:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955158
Page 119 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-08-2021 11:39:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/25/2021Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955159
Page 120 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-08-2021 11:40:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-08-2021 11:40:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-08-2021 11:40:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955160
Page 121 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 11:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 11:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 11:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 11:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 11:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021 11:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRN1J9Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955161
Page 122 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 11:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRN1J9Initial Entry
5.b
Date Location User Value Reason
Mar-08-2021 11:44:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS238NInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-08-2021 11:44:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS238NInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021 11:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS237JInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-08-2021 11:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS237JInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955162
Page 123 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 11:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 11:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 11:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 11:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 11:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021 11:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRN1H2Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955163
Page 124 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 11:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRN1H2Initial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955164
Page 125 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021 09:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955165
Page 126 of 128
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-08-2021 11:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955166
Page 127 of 128
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020 15:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020 21:39:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
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Time (US & Canada)ACV0PFEINFP6000 auto calc
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Time (US & Canada)ACV0PFEINFP6000 auto calc
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090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955167
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***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791183 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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1. Casebook Signature
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Oct-21-2020 12:39:44
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Time (US & Canada)ACV0PFEINFP6000 Data Entry:
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090177e196ae2f21\Final\Final On: 01-Apr-2021 03:35 (GMT)
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FDA-CBER-2021-5683-0955168