125742 S1 M5 CRF c4591001 1092 10921120

Document text

Page 1 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923397
Page 2 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923398
Page 3 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10921120]
2.Birth Date: /1949
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923399
Page 4 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923400
Page 5 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923401
Page 6 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923402
Page 7 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[dyslipidemia]
Start Date: UNK/UNK/1993
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis of the spine]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis of the neck]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923403
Page 8 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [201.1]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923404
Page 9 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [247440]
3.Randomization Group: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923405
Page 10 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BL9TXB]
5.bSample ID [BL9TXC]
5.cSample ID [BN5X1N]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923406
Page 11 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BN5X0N]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923407
Page 12 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/1/2020 08:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923408
Page 13 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923409
Page 14 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923410
Page 15 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923411
Page 16 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BM9KZ4]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923412
Page 17 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/22/2020 07:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923413
Page 18 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923414
Page 19 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BSJR00]
5.bSample ID [BR961D]
5.cSample ID [BSJPZN]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923415
Page 20 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923416
Page 21 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/6/2020
2.Date of First Symptom
Started:Oct/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923417
Page 22 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923418
Page 23 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
 1.Not Applic
able Not Appli
cable Not Applicable  Not Applicable  Not Appli
cable Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923419
Page 24 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923420
Page 25 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV23021]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923421
Page 26 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Self swab completed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923422
Page 27 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923423
Page 28 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923424
Page 29 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0923425
Page 30 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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FDA-CBER-2021-5683-0923426
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923427
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923428
Page 33 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0923430
Page 35 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0923431
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923432
Page 37 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923434
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923436
Page 41 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923438
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0923440
Page 45 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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.Start Date: //
6.Ongoing?
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0923442
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923444
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BM9L8L]
5.bSample ID [BSJR65]
5.cSample ID [BSJR69]
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(b) (4)
FDA-CBER-2021-5683-0923445
Page 50 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923446
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
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(b) (4)
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***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923448
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***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923449
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***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923450
Page 55 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923451
Page 56 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Urinary Tract Inf
ection Oct/6/2020
UNK:UNK NO
End Date Time:
Oct/10/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  Vertigo  Jan/16/2021
UNK:UNK NO
End Date Time:
Jan/18/2021 UN
K:UNK
 Repeating
Pages
 3.ADVERS
E EVENT 3  Hypokalemia  Jan/16/2021
UNK:UNK NO
End Date Time:
Jan/16/2021 UN
K:UNK
 Repeating
Pages
 4.ADVERS
E EVENT 4  Transient Ischem
ic Attack (TIA) Jan/16/2021
UNK:UNK NO
End Date Time:
Jan/16/2021 UN
K:UNK
 Repeating
Pages
 5.ADVERS
E EVENT 5  Elevated Blood P
ressure Jan/16/2021
UNK:UNK NO
End Date Time:
Jan/16/2021 UN
K:UNKRepeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923452
Page 57 of 284
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 
 6.ADVERS
E EVENT 6  Nausea  Jan/16/2021
UNK:UNK NO
End Date Time:
Jan/16/2021 UN
K:UNK
 Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923453
Page 58 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Urinary Tract Infection]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/10/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923454
Page 59 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNK]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923455
Page 60 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923456
Page 61 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Vertigo]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/18/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923457
Page 62 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923458
Page 63 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021046444]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923459
Page 64 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Hypokalemia]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923460
Page 65 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923461
Page 66 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923462
Page 67 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Transient Ischemic Attack (TIA)]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923463
Page 68 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923464
Page 69 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021046444]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923465
Page 70 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Elevated Blood Pressure]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923466
Page 71 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923467
Page 72 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923468
Page 73 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Nausea]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923469
Page 74 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923470
Page 75 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923471
Page 76 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923472
Page 77 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923473
Page 78 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923474
Page 79 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923475
Page 80 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923476
Page 81 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923477
Page 82 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923478
Page 83 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923479
Page 84 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923480
Page 85 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923481
Page 86 of 284
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923482
Page 87 of 284
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923483
Page 88 of 284
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923484
Page 89 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923485
Page 90 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923486
Page 91 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923487
Page 92 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923488
Page 93 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923489
Page 94 of 284
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923490
Page 95 of 284
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923491
Page 96 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923492
Page 97 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923493
Page 98 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923494
Page 99 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923495
Page 100 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNVLMT]
5.bSample ID [BM9LHC]
5.cSample ID [BNVLMH]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923496
Page 101 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9LHK]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923497
Page 102 of 284
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 07:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923498
Page 103 of 284
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923499
Page 104 of 284
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBT0K]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923500
Page 105 of 284
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/15/2021 07:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923501
Page 106 of 284
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923502
Page 107 of 284
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923503
Page 108 of 284
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923504
Page 109 of 284
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923505
Page 110 of 284
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923506
Page 111 of 284
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923507
Page 112 of 284
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923508
Page 113 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923509
Page 114 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923510
Page 115 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-03-2021 13:22:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923511
Page 116 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-01-2020 09:45:27 (UTC-05:00)
Eastern Time (US & Canada)All inclusion/exclusion criteria met
Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923512
Page 117 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
FormOct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923513
Page 118 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
1Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
1Oct-13-2020 14:32:58 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0923514
Page 119 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
2Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923515
Page 120 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
3Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923516
Page 121 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
4Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923517
Page 122 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
5Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923518
Page 123 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
6Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923519
Page 124 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
7Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923520
Page 125 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
8Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0923521
Page 126 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Oct-16-2020 07:49:57 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer we
do not know if subject tested positive
or not this test was not done on site.
changed answer to NA instead of not
done is this what your looking for?
Please advise
Not Applicable
9Oct-14-2020 15:02:31 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
Not Done
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923522
Page 127 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-15-2020 07:57:13 (UTC-05:00)
Eastern Time (US & Canada)self swab done and sent to Pfizer
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923523
Page 128 of 284
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-22-2021 08:36:23 (UTC-05:00)
Eastern Time (US & Canada)Kofi Amoah Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0923524
Page 129 of 284
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-22-2021 08:36:23 (UTC-05:00)
Eastern Time (US & Canada)Kofi Amoah Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0923525
Page 130 of 284
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-22-2021 08:36:45 (UTC-05:00)
Eastern Time (US & Canada)Kofi Amoah Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0923526
Page 131 of 284
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-22-2021 08:36:45 (UTC-05:00)
Eastern Time (US & Canada)Kofi Amoah Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0923527
Page 132 of 284
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-25-2021 07:50:27 (UTC-05:00)
Eastern Time (US & Canada)All inclusion and exclusion criteria
met
Not Applicable
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923528
Page 133 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-03-2021 13:22:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-25-2021 07:50:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 14:10:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923529
Page 134 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-19-2021 13:25:25 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-16-2020 10:44:05 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923530
Page 135 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
 N/A Nov-12-2020 14:16:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-03-2020 09:23:44 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923531
Page 136 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020
09:36:30
(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-01-2020
09:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923532
Page 137 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020
09:36:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/1/2020Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923533
Page 138 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020
09:36:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10921120Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020
09:36:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020
09:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923534
Page 139 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020
09:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020
09:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923535
Page 140 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020
09:45:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923536
Page 141 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020
09:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020
09:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020
09:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923537
Page 142 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020
09:46:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:dyslipide
mia
Start Date: UNK/U
NK/199
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:46:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:46:29
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
dyslipidemiaInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923538
Page 143 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-01-2020
09:46:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020
09:46:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-01-2020
09:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:osteoarthri
tis of the s
pine
Start Date
:UNK/UN
K/2008
Ongoing: YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923539
Page 144 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritis of the s
pineInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020
09:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020
09:47:27ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0923540
Page 145 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-01-2020
09:48:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:osteoarthri
tis of the n
eck
Start Date
:UNK/UN
K/2008
Ongoing: YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0923541
Page 146 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:48:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:48:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritis of the n
eckInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020
09:48:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020
09:48:02ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0923542
Page 147 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0923543
Page 148 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
201.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923544
Page 149 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.3Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.8Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923545
Page 150 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923546
Page 151 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
09:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923547
Page 152 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020
09:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020
09:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
247440Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923548
Page 153 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
09:53:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
09:53:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
09:54:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
09:53:55
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923549
Page 154 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
09:53:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
09:54:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BL9TX
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
09:54:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9TXBInitial Entry
5.b
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923550
Page 155 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020
09:54:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BL9TX
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
09:54:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9TXCInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
10:56:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN5X1
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
10:56:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5X1NInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923551
Page 156 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
09:53:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
09:53:23
(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-01-2020
09:53:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
09:53:23
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923552
Page 157 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
09:53:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
09:53:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN5X0
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
09:53:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5X0NInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923553
Page 158 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923554
Page 159 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 08:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
09:51:07
(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-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923555
Page 160 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
09:51:07
(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-01-2020
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923556
Page 161 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-01-2020
09:51:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923557
Page 162 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020
08:19:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923558
Page 163 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:97.4
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923559
Page 164 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
09:02:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923560
Page 165 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
08:20:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
08:20:08
(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-22-2020
08:20:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
08:20:08
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923561
Page 166 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-22-2020
08:20:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
08:20:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM9KZ
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
08:20:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9KZ4Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923562
Page 167 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923563
Page 168 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 07:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
09:02:10
(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-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923564
Page 169 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020
09:02:10
(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-22-2020
09:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923565
Page 170 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
08:14:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923566
Page 171 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
08:15:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
08:15:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
08:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
08:15:33
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923567
Page 172 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
08:15:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
08:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJR00Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
08:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJR00Initial Entry
5.b
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923568
Page 173 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-20-2020
08:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR961
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
08:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR961DInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020
08:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSJPZ
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
08:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJPZNInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923569
Page 174 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
08:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Closed As per
comment on
covid test, test
was not done
on site
Oct-16-2020
07:51:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answere
dPlease see note
under covid test
page and advise
site if this
answer is
correct
Oct-16-2020
04:57:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Reissued:
OpenedDM2: Kindly
review and
confirm if data
for
Microbiology
Specimen form
was collected,
else clarify.
Oct-15-2020
07:59:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answere
dSorry but I do
not know
understand
what form is for
microbiology at
illness visit
please advise
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923570
Page 175 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-15-2020
02:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Reissued:
OpenedDM1: Thanks
for response,
kindly review
and complete
‘Microbiology
Specimen form'
at this visit.
Oct-14-2020
15:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answere
dself swab done
and sent to
Pfizer lab
Oct-14-2020
03:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen form'
at this visit.
Thank you.
Oct-06-2020
10:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-06-2020
09:51:41ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0923571
Page 176 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Oct-06-2020
09:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Oct-06-2020
09:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-06-2020
09:51:41
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923572
Page 177 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923573
Page 178 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-13-2020
14:23:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-13-2020
14:14:15
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dNew
Information
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923574
Page 179 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
Nov-13-2020
14:14:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Sym
ptom Resolved:
Oct/10/2020New
Information
Nov-13-2020
13:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please clarify
whether the
reported
symptoms are
still ongoing? If
symptoms have
ended, please
update
‘Symptoms
Ongoing’ on to
‘NO’ and add
Date of Last
Symptom
Resolved on the
CRF.
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923575
Page 180 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASEInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923576
Page 181 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)D COUGH
Sympt
om Pre
sent:NO
4.b Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923577
Page 182 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symp
tom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:YESInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923578
Page 183 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.d Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923579
Page 184 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.e Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923580
Page 185 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.f Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923581
Page 186 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.g Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923582
Page 187 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.h Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923583
Page 188 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i Symptoms:
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-06-2020
09:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923584
Page 189 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-13-2020
14:32:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923585
Page 190 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-16-2020
07:49:57ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0923586
Page 191 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923587
Page 192 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-16-2020
07:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-14-2020
15:02:31
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923588
Page 193 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923589
Page 194 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
10:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
10:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
10:38:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
10:38:32
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923590
Page 195 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
10:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
10:38:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:CV2302
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
10:38:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CV23021Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923591
Page 196 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
14:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
14:33:26
(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-13-2020
14:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923592
Page 197 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-13-2020
14:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Self swab completedInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923593
Page 198 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923594
Page 199 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMER
GENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923595
Page 200 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923596
Page 201 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Type of P
ractitioneTELEPH
ONE COInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923597
Page 202 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)r: NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:OT
HE
RInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923598
Page 203 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) Occurrence of
Visits or Conta
cts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-06-2020
09:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923599
Page 204 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-06-2020
09:59:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-06-2020
09:59:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
10:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-07-2020
09:29:10
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923600
Page 205 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/06/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
Oct-07-2020
09:29:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Changed
Information
Oct-07-2020
08:59:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
As subject is
symptomatic,
per CCG's
toxicity grade
from 1-5
should be
entered. Please
update.
Oct-06-2020
09:59:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
0Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923601
Page 206 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020
14:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-12-2020
14:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923602
Page 207 of 284
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020
14:17:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020
14:17:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020
14:17:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-12-2020
14:17:07
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923603
Page 208 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-12-2020
14:17:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020
14:17:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM9L8
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020
14:17:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9L8LInitial Entry
5.b
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923604
Page 209 of 284
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-12-2020
14:18:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJR65Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020
14:18:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJR65Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020
14:19:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJR69Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020
14:19:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSJR69Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923605
Page 210 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
08:18:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Changed
Information
Oct-16-2020
10:45:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
10:45:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
10:45:01
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923606
Page 211 of 284
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923607
Page 212 of 284
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923608
Page 213 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923609
Page 214 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-12-2021
10:24:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923610
Page 215 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-12-2021
10:25:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923611
Page 216 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-12-2021
10:26:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923612
Page 217 of 284
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-12-2021
10:27:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923613
Page 218 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Urinary Tract Infecti
onInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923614
Page 219 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-20-2020
08:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/10/2020 U
NK:UNKNew
Information
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923615
Page 220 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020
11:45:31
(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:Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923616
Page 221 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
OTHER
If Other, specify
:
UNK
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923617
Page 222 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-20-2020
08:26:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Clo
sedClose Auto Query
Oct-20-2020
08:26:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERE
D/RESOLV
EDNew Information
Oct-20-2020
08:18:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Op
enedFor AE Urinary Tract
Infection: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERI
NG/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923618
Page 223 of 284
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020
11:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923619
Page 224 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-23-2021
17:02:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-12-2021
10:23:15ACV0PFEINFP6000  Query 1: Answered Updated
report sent
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0923620
Page 225 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
Jan-27-2021
22:29:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical
Please update
SAE with
medical
records
information
on workup for
the event
Vertigo,
including
laboratory and
imaging
results
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VertigoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/16/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923621
Page 226 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Jan-21-2021
08:54:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-20-2021
13:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered End date listed
on p.2 of
Initial SAE
Jan-20-2021
10:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical End
date is
18Dec20;
however, SAE
report has no
end date.
Please submit
a SAE safety
update with
this
information
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/18/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923622
Page 227 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
Jan-27-2021
22:23:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Jan-20-2021
13:09:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answere
dPending
medical records
Jan-20-2021
10:25:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923623
Page 228 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
submit a
follow-up SAE
form
[#2021046444]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date
and results.
Jan-20-2021
07:20:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teFor AE Vertigo:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth dInitial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923624
Page 229 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
efect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or signi
ficant disability/
incapacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically
important seriou
s event
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923625
Page 230 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-19-2021
13:25:25
(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
Jan-19-2021
13:25:25
(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
:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923626
Page 231 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-19-2021
13:25:25
(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
Mar-01-2021
11:16:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-24-2021
07:20:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dNew
Information
Feb-24-2021
07:20:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESNew
Information
Feb-23-2021
17:04:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Con
Med for SAE
is NO;
however, SAE
report states
subject
received
meclizine for
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923627
Page 232 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
vertigo. Please
review Con
meds,
harmonize
reporting, and
update where
applicable
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021
13:25:25
(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
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923628
Page 233 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Jan-19-2021
13:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-21-2021
01:31:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2021046444Initial Entry
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0923629
Page 234 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021
10:24:20
(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-12-2021
10:24:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021
10:24:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypokalemiaInitial Entry
4. Start Date Time:
090177e196ae306d\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923630
Page 235 of 284
***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, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921120 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Feb-12-2021
10:24:20
(UTC
…[truncated]