Document text
Page 1 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966838
Page 2 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/18/2020
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966839
Page 3 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10881220]
2.Birth Date: /1971
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966840
Page 4 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966841
Page 5 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966842
Page 6 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966843
Page 7 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[allergic rhinitis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[headaches]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966844
Page 8 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [76.4]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [27.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966845
Page 9 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966846
Page 10 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [93296]
3.Randomization Group: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966847
Page 11 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BN5VKC]
5.bSample ID [BN5VKD]
5.cSample ID [BN5VKF]
5.dSample ID [BRTN3M]
5.eSample ID [BRTN3N]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966848
Page 12 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP976M]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966849
Page 13 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 10:08
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
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966850
Page 14 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966851
Page 15 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966852
Page 16 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966853
Page 17 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/9/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966854
Page 18 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2S4K]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966855
Page 19 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/9/2020 13:41
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
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966856
Page 20 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966857
Page 21 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BRFFVD]
5.bSample ID [BRFFVF]
5.cSample ID [BRFFVG]
5.dSample ID [BRZF9T]
5.eSample ID [BRZF9V]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966858
Page 22 of 144
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966859
Page 23 of 144
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966860
Page 24 of 144
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966861
Page 25 of 144
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966862
Page 26 of 144
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966863
Page 27 of 144
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966864
Page 28 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966865
Page 29 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966866
Page 30 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966867
Page 31 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966868
Page 32 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966869
Page 33 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966870
Page 34 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966871
Page 35 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966872
Page 36 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966873
Page 37 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966874
Page 38 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966875
Page 39 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966876
Page 40 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 right frontal m
eningioma Sep/23/2020
UNK:UNK YES Repeating
Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966877
Page 41 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[right frontal meningioma]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966878
Page 42 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966879
Page 43 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020425870]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966880
Page 44 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966881
Page 45 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966882
Page 46 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966883
Page 47 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966884
Page 48 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966885
Page 49 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966886
Page 50 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966887
Page 51 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966888
Page 52 of 144
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966889
Page 53 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966890
Page 54 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966891
Page 55 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966892
Page 56 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966893
Page 57 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966894
Page 58 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966895
Page 59 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966896
Page 60 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966897
Page 61 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966898
Page 62 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966899
Page 63 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966900
Page 64 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966901
Page 65 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966902
Page 66 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966903
Page 67 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966904
Page 68 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966905
Page 69 of 144
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966906
Page 70 of 144
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966907
Page 71 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966908
Page 72 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966909
Page 73 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Feb-22-2021 15:09:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966910
Page 74 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-18-2020 16:39:34 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966911
Page 75 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Feb-22-2021 15:09:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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-18-2021 12:21:43 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 15:13:07 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966912
Page 76 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, 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.
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966913
Page 77 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-18-2020
16:38:00
(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
Sep-18-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966914
Page 78 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020
16:38:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/18/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966915
Page 79 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020
16:37:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10881220Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020
16:37:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1971Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020
16:39:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966916
Page 80 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
16:39:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-18-2020
16:39:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966917
Page 81 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
16:39:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966918
Page 82 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966919
Page 83 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020
16:40:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:allergic r
hinitis
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:40:19
(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
Sep-18-2020
16:40:19
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
allergic rhinitisInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966920
Page 84 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-18-2020
16:40:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-18-2020
16:40:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-18-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:headach
es
Start Date: UNK/U
NK/200
9
Ongoing: YESInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966921
Page 85 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:40:38
(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
Sep-18-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
headachesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020
16:40:38ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966922
Page 86 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966923
Page 87 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
76.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966924
Page 88 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.4Initial Entry
7.a
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:98.0Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966925
Page 89 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966926
Page 90 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
16:41:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966927
Page 91 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966928
Page 92 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966929
Page 93 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
16:41:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966930
Page 94 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020
16:42:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020
16:42:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
93296Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966931
Page 95 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
16:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
16:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
16:43:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
16:42:56
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966932
Page 96 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
16:42:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
16:43:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN5VK
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
16:43:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5VKCInitial Entry
5.b
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966933
Page 97 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
16:43:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN5VK
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020
16:43:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5VKDInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020
16:43:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN5VK
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020
16:43:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5VKFInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966934
Page 98 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d
Date Location User Value Reason
Sep-18-2020
16:44:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTN3
MInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-18-2020
16:44:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTN3MInitial Entry
5.e
Date Location User Value Reason
Sep-18-2020
16:45:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTN3
NInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966935
Page 99 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.e Sample ID
Date Location User Value Reason
Sep-18-2020
16:45:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTN3NInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966936
Page 100 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
16:46:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
16:46:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
16:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
16:46:24
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966937
Page 101 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
16:46:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
16:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP976
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
16:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP976MInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966938
Page 102 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966939
Page 103 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 10:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966940
Page 104 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-18-2020
16:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966941
Page 105 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-18-2020
16:48:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966942
Page 106 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020
18:51:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966943
Page 107 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:97.3
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966944
Page 108 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.a Temperature:
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-09-2020
18:52:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966945
Page 109 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966946
Page 110 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966947
Page 111 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-09-2020
18:52:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966948
Page 112 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020
18:52:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020
18:52:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
18:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-09-2020
18:52:54
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966949
Page 113 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-09-2020
18:52:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
18:53:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR2S4
Kupdated
Oct-09-2020
18:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR2S4L
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
18:53:42
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966950
Page 114 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
Oct-09-2020
18:53:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR2S4Kupdated
Oct-09-2020
18:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Oct-09-2020
18:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR2S4LKInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966951
Page 115 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966952
Page 116 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020 13:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966953
Page 117 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-09-2020
18:54:12
(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
Oct-09-2020
18:54:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966954
Page 118 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020
15:24:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966955
Page 119 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020
15:24:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020
15:24:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
15:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-06-2020
15:24:11
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966956
Page 120 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-06-2020
15:24:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020
15:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRFFV
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020
15:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRFFVDInitial Entry
5.b
Date Location User Value Reason
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966957
Page 121 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-06-2020
15:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRFFV
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020
15:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRFFVFInitial Entry
5.c
Date Location User Value Reason
Nov-06-2020
15:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRFFV
GInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020
15:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRFFVGInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966958
Page 122 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d
Date Location User Value Reason
Nov-06-2020
15:24:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRZF9
TInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-06-2020
15:24:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRZF9TInitial Entry
5.e
Date Location User Value Reason
Nov-06-2020
15:25:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRZF9
VInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966959
Page 123 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.e Sample ID
Date Location User Value Reason
Nov-06-2020
15:25:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRZF9VInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966960
Page 124 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966961
Page 125 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Oct-09-2020
15:08:56
(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-09-2020
15:08:56
(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
Nov-02-2020
16:19:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-21-2020
18:50:06
(UTC-05:00)ACV0PFEINFP6000 Query 1: Answered YES
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966962
Page 126 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)
Oct-20-2020
08:59:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Steven De
BeukelaerQuery 1: Reissued:
OpenedGPDCLIN:
thank you. Yet
the diagnosis
was only
made now
recently,
correct ?
Oct-14-2020
14:36:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered cognitive
issues not
reported at
screening. Has
had symptoms
since June
2020.
Oct-12-2020
04:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Steven De
BeukelaerQuery 1: Opened GPDCLIN:
which
symptoms let
to this
diagnosis ?
When did they
start ? Was it
reported
before ?
Thank you.
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right frontal menin
giomaInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966963
Page 127 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4. Start Date Time:
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-09-2020
15:08:56
(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;
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966964
Page 128 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Nov-05-2020
11:14:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Nov-05-2020
09:07:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answe
redChanged
Information
Nov-05-2020
09:07:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious
event associat
ed with conge
nital anomaly
or birth defect
?
NO
Did this seriou
s event result i
n death?
NOChanged
Information
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966965
Page 129 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Did this seriou
s event require
or prolong hos
pitalization?
NO
Did this seriou
s event result i
n persistent or
significant dis
ability/incapac
ity?
NO
Is this serious
event life thre
atening?
NO
Other medicall
y important se
rious event
YES
Nov-04-2020
02:10:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed recorded in Safety
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966966
Page 130 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-03-2020
11:06:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opene
dClinical - SAE
report only records
1 SAE category
(Med Important);
however, AE CRF
shows 2
categories. Please
review and update
in the appropriate
location, so the
same
category/categories
are reported in
both locations.
Nov-03-2020
08:26:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opene
dSAE RECON:
right frontal
meningioma(Onset
date:18Sep2020) is
not reported to
Safety database
but marked serious
on AE CRF.
Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE CRF
Nov-03-2020
08:25:30
(UTC-05:00)ACV0PFEINFP6000 Query 2: Closed not yet reported in
sdb
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966967
Page 131 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)
Nov-03-2020
05:36:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dFor AE right
frontal
meningioma:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-02-2020
12:43:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response satisfies
query
Nov-02-2020
12:37:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candi
dateFor AE right
frontal
meningioma:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-02-2020
12:37:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redNew Information
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966968
Page 132 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-02-2020
12:37:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious
event associat
ed with conge
nital anomaly
or birth defect
?
NO
Did this seriou
s event result i
n death?
NO
Did this seriou
s event require
or prolong hos
pitalization?
YES
Did this seriou
s event result i
n persistent or
significant dis
ability/incapac
ity?
NO
Is this seriousNew Information
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966969
Page 133 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
event life thre
atening?
NO
Other medicall
y important se
rious event
YES
Oct-19-2020
18:45:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Opene
dGPD Clin: Since
this AE could be
considered as an
important medical
event, please
consider reporting
this event as an
SAE. Thank you.
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966970
Page 134 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this even
t is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966971
Page 135 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-09-2020
15:08:56
(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
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966972
Page 136 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-04-2020
02:10:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020425870Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966973
Page 137 of 144
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-06-2020
15:25:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020
15:25:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020
15:25:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966974
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***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966975
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***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
12:22:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
12:21:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-18-2021
12:21:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NOT
confirmed to hav
e received only p
lacebo at VaccinaInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966976
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***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
tion 1/2
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966977
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***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
12:22:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
12:22:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0966978
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***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-06-2020
15:25:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-18-2020
16:42:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-18-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020
15:25:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
Sep-18-2020
16:42:20ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966979
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***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-18-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Initial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966980
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***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
15:12:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f9a\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966981