Document text
Page 1 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898257
Page 2 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898258
Page 3 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10211081]
2.Birth Date: /1953
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898259
Page 4 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898260
Page 5 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898261
Page 6 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898262
Page 7 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Strawberry Allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Prostate Cancer]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L Achilles Tendon Tear]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898263
Page 8 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Torn Ligament L Knee]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L Knee Osteoarthritis]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2016
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal Allergic Rhinitis]
Start Date: UNK/UNK/1961
Ongoing: YES
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898264
Page 9 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L Achilles Tendon Repair]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L Knee Torn Ligament Repair]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L Knee Replacement]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898265
Page 10 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Prostatectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.kLine/MH Number: [ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898266
Page 11 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [92.3]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [27.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898267
Page 12 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [237777]
3.Randomization Group: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898268
Page 13 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BPRXK6]
5.bSample ID [BPRXK7]
5.cSample ID [BP9D09]
5.dSample ID [BP9D0B]
5.eSample ID [BP9D0C]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898269
Page 14 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP9CW6]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898270
Page 15 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/24/2020 09:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898271
Page 16 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898272
Page 17 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898273
Page 18 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898274
Page 19 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9DD0]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898275
Page 20 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 15:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898276
Page 21 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898277
Page 22 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLX701]
5.bSample ID [BSHLBY]
5.cSample ID [BSHLBZ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898278
Page 23 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898279
Page 24 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898280
Page 25 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898281
Page 26 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898282
Page 27 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898283
Page 28 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898284
Page 29 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898285
Page 30 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898286
Page 31 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898287
Page 32 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898288
Page 33 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898289
Page 34 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898290
Page 35 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898291
Page 36 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898292
Page 37 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 L Knee S
prain Oct/14/2020 U
NK:UNK NO
End Date Time:
Oct/21/2020 UNK:
UNK
Repeating
Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898293
Page 38 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[L Knee Sprain]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/21/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898294
Page 39 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to drug/non-drug treatment]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898295
Page 40 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898296
Page 41 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898297
Page 42 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898298
Page 43 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898299
Page 44 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898300
Page 45 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898301
Page 46 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898302
Page 47 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898303
Page 48 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898304
Page 49 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898305
Page 50 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898306
Page 51 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898307
Page 52 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898308
Page 53 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898309
Page 54 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898310
Page 55 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898311
Page 56 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898312
Page 57 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898313
Page 58 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898314
Page 59 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898315
Page 60 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898316
Page 61 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898317
Page 62 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898318
Page 63 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898319
Page 64 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898320
Page 65 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BRDC7H]
5.bSample ID [BRTTWG]
5.cSample ID [BRTTWH]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898321
Page 66 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BN1ZT4]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898322
Page 67 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 08:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898323
Page 68 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898324
Page 69 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR170D]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898325
Page 70 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/10/2021 10:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898326
Page 71 of 176
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898327
Page 72 of 176
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898328
Page 73 of 176
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898329
Page 74 of 176
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898330
Page 75 of 176
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898331
Page 76 of 176
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898332
Page 77 of 176
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898333
Page 78 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898334
Page 79 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898335
Page 80 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John
Rubino Approved Mar-12-2021 16:18:41 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898336
Page 81 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 09:41:52
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898337
Page 82 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-22-2021 08:38:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898338
Page 83 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John
Rubino Approved Mar-12-2021 16:18:41 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-11-2021 14:30:17 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Mar-11-2021 07:53:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898339
Page 84 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, JohnRubino, 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-25-2021 13:11:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Jan-22-2021 12:21:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898340
Page 85 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Jan-21-2021 16:10:26 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Oct-20-2020 19:50:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898341
Page 86 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020
09:40:35
(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-24-2020
09:40:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898342
Page 87 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020
09:40:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/24/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898343
Page 88 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020
09:40:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10211081Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020
09:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1953Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
09:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898344
Page 89 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
09:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020
09:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898345
Page 90 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020
09:41:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898346
Page 91 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020
09:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020
09:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020
09:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898347
Page 92 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020
09:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Strawber
ry Allerg
y
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:42:41
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Strawberry AllergyInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898348
Page 93 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-24-2020
09:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020
09:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-24-2020
09:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Prostate C
ancer
Start Date
:UNK/UN
K/2017Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898349
Page 94 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date
:
UNK/U
NK/201
7
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898350
Page 95 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Prostate CancerInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020
09:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020
09:42:56ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898351
Page 96 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/201
7
1.c
Date Location User Value Reason
Aug-24-2020
09:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:L Achilles
Tendon Tea
r
Start Dat
e:UNK/UNK
/1980
Ongoing: NO
End Date:
UNK/U
NK/198
0Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898352
Page 97 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Achilles Tendon
TearInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020
09:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020
09:43:14ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898353
Page 98 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/198
0
1.d
Date Location User Value Reason
Aug-24-2020
09:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Torn Liga
ment L Kn
ee
Start Dat
e:UNK/UNK
/1985
Ongoing: NO
End Date:
UNK/U
NK/198
5Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898354
Page 99 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Torn Ligament L K
neeInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020
09:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020
09:43:43ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898355
Page 100 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/198
5
1.e
Date Location User Value Reason
Aug-24-2020
09:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:L Knee Ost
eoarthritis
Start Date
:UNK/UNK
/1990
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898356
Page 101 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Knee Osteoarthrit
isInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020
09:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020
09:44:16ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898357
Page 102 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/201
6
1.f
Date Location User Value Reason
Aug-24-2020
09:44:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History T
erm:Seasonal
Allergic R
hinitis
Start Dat
e:UNK/UN
K/1961
Ongoing: YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898358
Page 103 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:44:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:44:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Seasonal Allergic R
hinitisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020
09:44:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1961Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020
09:44:41ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898359
Page 104 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
1.g
Date Location User Value Reason
Aug-24-2020
09:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:L Achilles
Tendon Rep
air
Start Dat
e:UNK/UNK/
1980
Ongoing: NO
End Date:
UNK/U
NK/198
0Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898360
Page 105 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Achilles Tendon
RepairInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020
09:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020
09:45:21ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898361
Page 106 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/198
0
1.h
Date Location User Value Reason
Aug-24-2020
09:48:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:8
Medical
History
Term:L Knee Torn
Ligament Re
pair
Start Da
te:UNK/UNK/
1985
Ongoing
:NO
End Date:
UNK/UN
K/1985Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898362
Page 107 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:48:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:48:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Knee Torn Ligam
ent RepairInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-24-2020
09:48:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-24-2020
09:48:52ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898363
Page 108 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/198
5
1.i
Date Location User Value Reason
Aug-24-2020
09:49:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:L Knee Re
placement
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898364
Page 109 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:49:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:49:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Knee Replaceme
ntInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-24-2020
09:49:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-24-2020
09:49:46ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898365
Page 110 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/201
6
1.j
Date Location User Value Reason
Aug-24-2020
09:50:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:Prostatecto
my
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
UNK/U
NK/201
7Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898366
Page 111 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-24-2020
09:50:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:50:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ProstatectomyInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-24-2020
09:50:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-24-2020
09:50:19ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898367
Page 112 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/201
7
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898368
Page 113 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898369
Page 114 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
92.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898370
Page 115 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
182.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.9Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.2Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898371
Page 116 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Locatio
n::FORE
HEA
D
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898372
Page 117 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
09:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898373
Page 118 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020
10:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020
10:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
237777Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898374
Page 119 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
10:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
10:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
10:17:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
10:08:17
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898375
Page 120 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
10:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
10:17:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPRXK
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
10:17:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPRXK6Initial Entry
5.b
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898376
Page 121 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-24-2020
10:18:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPRXK
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020
10:18:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPRXK7Initial Entry
5.c
Date Location User Value Reason
Aug-24-2020
10:18:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9D0
9Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898377
Page 122 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-24-2020
10:18:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9D09Initial Entry
5.d
Date Location User Value Reason
Aug-24-2020
10:18:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9D0
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-24-2020
10:18:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9D0BInitial Entry
5.e
Date Location User Value Reason
Aug-24-2020
10:18:44ACV0PFEINFP6000 Data Entry:
Sample ID BP9D0Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898378
Page 123 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada): C
5.e Sample ID
Date Location User Value Reason
Aug-24-2020
10:18:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9D0CInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898379
Page 124 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
10:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
10:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
10:16:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
10:08:28
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898380
Page 125 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
10:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
10:16:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9CW
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
10:16:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9CW6Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898381
Page 126 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898382
Page 127 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 09:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020
10:08:48
(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-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898383
Page 128 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-24-2020
10:08:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898384
Page 129 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020
10:08:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898385
Page 130 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020
15:59:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898386
Page 131 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:98.4
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898387
Page 132 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature:
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898388
Page 133 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020
16:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020
16:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020
16:04:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-15-2020
16:00:48
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898389
Page 134 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-15-2020
16:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020
16:04:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9DD
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020
16:04:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9DD0Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898390
Page 135 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898391
Page 136 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 15:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898392
Page 137 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-15-2020
16:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898393
Page 138 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020
15:07:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898394
Page 139 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
15:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
15:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
15:11:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
15:07:24
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898395
Page 140 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-13-2020
15:07:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
15:11:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLX701Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
15:11:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLX701Initial Entry
5.b
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898396
Page 141 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
15:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSHLB
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020
15:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSHLBYInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020
15:12:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSHLB
ZInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898397
Page 142 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-13-2020
15:12:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSHLBZInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898398
Page 143 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-13-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898399
Page 144 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898400
Page 145 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
L Knee SprainInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898401
Page 146 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021
14:30:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-11-2021
14:30:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/21/2020 U
NK:UNKTranscription
Error
Mar-11-2021
14:30:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For L Knee
Sprain End
Date 21/Oct
/2021, is a
future date
relative to
when it was
entered on
11/Mar/2021.
Please correct.
Mar-11-2021
14:30:17ACV0PFEINFP6000 Data Entry:
NONew
Information
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898402
Page 147 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time
(US & Canada)End Date Time:
Oct/21/2021 U
NK:UNK
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898403
Page 148 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due to
:
OTHER
If Other, specify
:
Not related to
drug/non-dru
g treatmentInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898404
Page 149 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
14:30:47
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Cl
osedClose Auto Query
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898405
Page 150 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Mar-11-2021
14:30:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
RECOVER
ED/RESOL
VEDNew Information
Mar-11-2021
14:30:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedFor AE L Knee
Sprain: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
RECOVERI
NG/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-15-2020
09:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898406
Page 151 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021
16:10:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898407
Page 152 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-21-2021
16:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-21-2021
16:10:34
(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.
Jan-21-2021
16:10:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible per local
/national recom
mendations and
confirmed to haInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898408
Page 153 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ve received only
placebo at Vacci
nation 1/2
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898409
Page 154 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-21-2021
16:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-21-2021
16:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898410
Page 155 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021
08:38:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898411
Page 156 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-22-2021
08:38:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Jan/22/2021Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898412
Page 157 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-22-2021
08:38:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-22-2021
08:38:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-22-2021
08:38:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898413
Page 158 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
08:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
08:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
08:39:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
08:38:52
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898414
Page 159 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
08:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
08:39:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRDC7
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
08:39:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRDC7HInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898415
Page 160 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
08:40:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTTW
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021
08:40:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTTWGInitial Entry
5.c
Date Location User Value Reason
Jan-22-2021
08:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTTW
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-22-2021
08:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTTWHInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898416
Page 161 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
08:39:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
08:39:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
08:40:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
08:39:02
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898417
Page 162 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
08:39:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
08:40:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN1ZT4Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
08:40:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN1ZT4Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898418
Page 163 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898419
Page 164 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 08:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898420
Page 165 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Jan-22-2021
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-22-2021
08:39:23
(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
Jan-22-2021
08:39:23
(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
Jan-22-2021
08:39:23ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898421
Page 166 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898422
Page 167 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
13:11:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898423
Page 168 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
13:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
13:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021
13:11:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-25-2021
13:11:42
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898424
Page 169 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
13:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-25-2021
13:11:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR170DInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-25-2021
13:11:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR170DInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898425
Page 170 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898426
Page 171 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021 10:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898427
Page 172 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-25-2021
13:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-25-2021
13:12:26ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898428
Page 173 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898429
Page 174 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-24-2020
10:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-24-2020
09:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-13-2020
15:07:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-24-2020
10:07:59ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898430
Page 175 of 176
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-24-2020
09:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898431
Page 176 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020
11:28:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d1a\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898432