125742 S1 M5 CRF c4591001 1089 10891273

Document text

Page 1 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968701
Page 2 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/9/2020
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968702
Page 3 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10891273]
2.Birth Date: /2000
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968703
Page 4 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968704
Page 5 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968705
Page 6 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968706
Page 7 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:[penicillin drug allergy]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968707
Page 8 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [138.4]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [22.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968708
Page 9 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968709
Page 10 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [85566]
3.Randomization Group: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968710
Page 11 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/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 [BNW69N]
5.bSample ID [BNW69P]
5.cSample ID [BPYH0G]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968711
Page 12 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/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 [BP9RT0]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968712
Page 13 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/9/2020 14:49
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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968713
Page 14 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968714
Page 15 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968715
Page 16 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968716
Page 17 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/2/2020
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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968717
Page 18 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/2/2020
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 [BP9S1B]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968718
Page 19 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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/2/2020 15:51
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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968719
Page 20 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968720
Page 21 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BRBZ4R]
5.bSample ID [BSJN1K]
5.cSample ID [BSJN1J]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968721
Page 22 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968722
Page 23 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968723
Page 24 of 146
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968724
Page 25 of 146
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968725
Page 26 of 146
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968726
Page 27 of 146
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968727
Page 28 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968728
Page 29 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968729
Page 30 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968730
Page 31 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968731
Page 32 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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?
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968732
Page 33 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968733
Page 34 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968734
Page 35 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968735
Page 36 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968736
Page 37 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968737
Page 38 of 146
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968738
Page 39 of 146
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968739
Page 40 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968740
Page 41 of 146
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968741
Page 42 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure durin
g Pregnancy Dec/25/2020
UNK:UNK YES  Repeating
Pages
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968742
Page 43 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Exposure during Pregnancy]
4.Start Date Time: Dec/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968743
Page 44 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO Comments
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:
[subject of childbearing potential]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968744
Page 45 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968745
Page 46 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968746
Page 47 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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[ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968747
Page 48 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968748
Page 49 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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: //
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968749
Page 50 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968750
Page 51 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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?
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968751
Page 52 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968752
Page 53 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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?
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968753
Page 54 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968754
Page 55 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968755
Page 56 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968756
Page 57 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968757
Page 58 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968758
Page 59 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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?
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968759
Page 60 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968760
Page 61 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968761
Page 62 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968762
Page 63 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968763
Page 64 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968764
Page 65 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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 [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968765
Page 66 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968766
Page 67 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968767
Page 68 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968768
Page 69 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968769
Page 70 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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: [ ]
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968770
Page 71 of 146
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968771
Page 72 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968772
Page 73 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cecil
Farrington Approved Mar-03-2021 00:08:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968773
Page 74 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-09-2020 17:28:05 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968774
Page 75 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-25-2021 10:24:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968775
Page 76 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Feb-25-2021 10:23:38 (UTC-05:00)
Eastern Time (US & Canada)
7Feb-25-2021 10:23:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968776
Page 77 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cecil
Farrington Approved Mar-03-2021 00:08:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-25-2021 10:23:08 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Feb-23-2021 23:23:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968777
Page 78 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, CecilFarrington, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-18-2021 09:09:52 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Cecil
Farrington Approved Nov-03-2020 12:03:46 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968778
Page 79 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:27:34
(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-09-2020
17:27:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968779
Page 80 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020
17:27:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/9/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968780
Page 81 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020
17:27:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10891273Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020
17:27:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/2000Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020
17:27:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968781
Page 82 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-09-2020
18:21:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LAT
INO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020
17:27:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968782
Page 83 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968783
Page 84 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:28:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020
17:28:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020
17:28:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968784
Page 85 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020
18:45:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical
History T
erm:penicilli
n drug al
lergy
Start Dat
e:UNK/U
NK/200
2
Ongoing: YESInitial Entry
Sep-09-2020
18:21:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:penicilli
n drug al
lergy
Start Dat
e:
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020
18:21:35ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968785
Page 86 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
18:21:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
penicillin drug aller
gyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-09-2020
18:45:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020
18:21:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968786
Page 87 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
138.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968787
Page 88 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.3Initial Entry
7.a
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.0Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968788
Page 89 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEA
D
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968789
Page 90 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020
18:20:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968790
Page 91 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020
18:20:32
(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-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968791
Page 92 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-09-2020
18:20:32
(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-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-09-2020
18:20:32
(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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968792
Page 93 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020
18:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968793
Page 94 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020
18:19:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020
18:19:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
85566Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968794
Page 95 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
17:28:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
17:28:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
17:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
17:28:39
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968795
Page 96 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:28:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
17:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNW69
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
17:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNW69NInitial Entry
5.b
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968796
Page 97 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-09-2020
17:59:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNW69
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-09-2020
17:59:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNW69PInitial Entry
5.c
Date Location User Value Reason
Sep-09-2020
18:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYH0
GInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968797
Page 98 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Sep-09-2020
18:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYH0GInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968798
Page 99 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
17:28:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
17:28:32
(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-09-2020
17:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
17:28:32
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968799
Page 100 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:28:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
17:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP9RT
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
17:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9RT0Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968800
Page 101 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968801
Page 102 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020 14:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
18:20:11
(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-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968802
Page 103 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
18:20:11
(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-09-2020
18:20:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968803
Page 104 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-09-2020
17:28:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0968804
Page 105 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-02-2020
17:03:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968805
Page 106 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2.a
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968806
Page 107 of 146
***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: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-02-2020
17:03:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968807
Page 108 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-02-2020
17:03:52
(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-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968808
Page 109 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-02-2020
17:03:52
(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-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-02-2020
17:03:52
(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:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968809
Page 110 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-02-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968810
Page 111 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
17:04:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
17:04:03
(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-02-2020
17:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
17:04:03
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968811
Page 112 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-02-2020
17:04:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
17:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP9S1
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020
17:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9S1BInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968812
Page 113 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968813
Page 114 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 15:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968814
Page 115 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-02-2020
17:04:41
(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-02-2020
17:04:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968815
Page 116 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-30-2020
15:17:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968816
Page 117 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020
15:18:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020
15:18:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020
15:18:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-30-2020
15:18:08
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968817
Page 118 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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-30-2020
15:18:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020
15:18:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRBZ4
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020
15:18:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRBZ4RInitial Entry
5.b
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0968818
Page 119 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-30-2020
15:19:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSJN1
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020
15:19:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJN1KInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020
15:19:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSJN1
JInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0968819
Page 120 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.c Sample ID
Date Location User Value Reason
Oct-30-2020
15:19:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJN1JInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968820
Page 121 of 146
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
15:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
15:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
15:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968821
Page 122 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968822
Page 123 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021
15:41:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Mar-02-2021
12:58:03
(UTC-05:00)ACV0PFEINFP6000  Query 4: Closed Response
satisfies query
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968823
Page 124 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)
Feb-26-2021
15:06:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answere
dTERM IS
UPDATED
AND IN
SAFETY
Feb-26-2021
15:05:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answere
dSUBMITTED
TO SAFETY
2/25/2021
Feb-26-2021
00:27:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued
:OpenedClinical please
update the
event term on
AE CRF AND
SAE to
Exposure
during
Pregnancy, per
guidelines
Feb-26-2021
00:27:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued
:OpenedClinical Please
use the 2-page
Exposure
during
Pregnancy
Supplemental
Form to report
OB history,
Father info and
Social habits;
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968824
Page 125 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
also submit
contraception
information
Feb-25-2021
10:53:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answere
dTranscription
Error
Feb-25-2021
10:53:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answere
dTranscription
Error
Feb-25-2021
10:53:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exposure during P
regnancyTranscription
Error
Feb-25-2021
10:41:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Opened Clinical please
update the
event term on
AE CRF AND
SAE to
Exposure
during
Pregnancy, per
guidelines
Feb-25-2021
10:41:11
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 1: Closed rewording
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0968825
Page 126 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Feb-25-2021
10:40:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-25-2021
10:37:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued
:OpenedClinical please
update the
event term on
AE CRF as
well to
Exposure
during
Pregnancy
Feb-25-2021
10:22:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answere
dupdated safety
Feb-25-2021
10:21:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dupdated safety
Feb-23-2021
18:28:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical Please
use the 2-page
Exposure
during
Pregnancy
Supplemental
Form to report
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0968826
Page 127 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
OB history,
Father info and
Social habits;
also submit
contraception
information
Feb-23-2021
18:25:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical PG
safety report
only included
date of 1st
Vaccination;
please submit
an update
reporting date
of Vaccination
#2
Feb-23-2021
18:18:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical As per
CRF CG
8.50.2.5, a
healthy
pregnancy is
not an AE term;
instead
“Exposure
During
Pregnancy”
will be
recorded as an
AE in the CRF
until 6 months
after the last
dose of study
intervention
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968827
Page 128 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-25-2021
10:43:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed LMP /
Estimated
conception
with different
dates
Feb-23-2021
18:22:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical
Estimated date
of Conception
is 25Dec20;
same as LMP
1st day. What
was this based
on (ie not
subject)? For
PG start date,
ultrasound
measurement
of the fetus
during the 1st
trimester is the
most accurate
method;
otherwise use
LMP
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0968828
Page 129 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/25/2020 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021
10:42:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-25-2021
10:24:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-25-2021
10:24:11
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968829
Page 130 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Feb-25-2021
10:24:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Feb-23-2021
18:17:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical As per
CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During
Pregnancy” is
reported as Not
Applicable
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968830
Page 131 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-26-2021
00:25:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-25-2021
10:49:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto
Query
Feb-25-2021
10:49:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dTranscription
Error
Feb-25-2021
10:49:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription
Error
Feb-25-2021
10:42:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued
:OpenedClinical As per
CRF CG
8.50.2.5, an
“Exposure
During
Pregnancy” is
not an SAE
[despite using
similar forms
to report
pregnancy];
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968831
Page 132 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
only abnormal
outcomes of
pregnancy are
evaluated for
serious criteria
Feb-25-2021
10:23:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidat
eFor AE
Pregnancy:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-25-2021
10:23:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or prInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968832
Page 133 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
olong hospitaliza
tion?
NO
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically i
mportant serious
event
YES
Feb-25-2021
10:23:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-25-2021
10:23:18
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968833
Page 134 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Feb-25-2021
10:23:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dTranscription
Error
Feb-25-2021
10:23:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Feb-24-2021
06:20:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Feb-23-2021
18:18:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical As per
CRF CG
8.50.2.5, an
“Exposure
During
Pregnancy” is
not an SAE
[despite using
similar forms
to report
pregnancy];
only abnormal
outcomes of
pregnancy are
evaluated for
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968834
Page 135 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
serious criteria
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE
Pregnancy:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or pr
olong hospitaliza
tion?
NOInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968835
Page 136 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically i
mportant 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.
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968836
Page 137 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
subject of chil
dbearing pote
ntialInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968837
Page 138 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021
01:57:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clos
edResponse satisfies
query
Mar-01-2021
04:34:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse satisfies
query
Feb-26-2021
15:17:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredCORRECTED TO
UNKNOWN PER
QUERY
Feb-26-2021
15:06:35ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ope
nedFor AE Exposure
during Pregnancy:
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0968838
Page 139 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time
(US & Canada)Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Feb-26-2021
15:06:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription Error
Feb-26-2021
15:06:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNTranscription Error
Feb-26-2021
04:42:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ope
nedSAE RECON:
AER#2021179185,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance ,
outcome should be
recorded as
UNKNOWN.
Please confirm and
update accordingly.
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968839
Page 140 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOV
ERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021
13:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968840
Page 141 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
09:10:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968841
Page 142 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
09:10:17
(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 Vaccina
tion 1/2Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968842
Page 143 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 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
09:09:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
09:09:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968843
Page 144 of 146
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
15:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-09-2020
18:19:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-09-2020
17:28:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
15:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Sep-09-2020
18:19:58ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968844
Page 145 of 146
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-09-2020
17:28:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968845
Page 146 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891273 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
11:33:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2f3f\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968846