125742 S1 M5 CRF c4591001 1124 11241207

Document text

Page 1 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931583
Page 2 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931584
Page 3 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11241207]
2.Birth Date: /1966
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:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931585
Page 4 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931586
Page 5 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931587
Page 6 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931588
Page 7 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid Reflux]
Start Date: UNK/UNK/1997
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/2000
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Rhinitis]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931589
Page 8 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [220.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [35.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931590
Page 9 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [87187]
3.Randomization Group: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931591
Page 10 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP9608]
5.bSample ID [BMNV8J]
5.cSample ID [BMNV8K]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931592
Page 11 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP9609]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931593
Page 12 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/10/2020 15:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931594
Page 13 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931595
Page 14 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931596
Page 15 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931597
Page 16 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP55HV]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931598
Page 17 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/30/2020 13:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931599
Page 18 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931600
Page 19 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BP55MH]
5.bSample ID [BMNVKC]
5.cSample ID [BMNVKD]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931601
Page 20 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931602
Page 21 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
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 [BP55SV]
5.bSample ID [BSFHPJ]
5.cSample ID [BSFHPK]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931603
Page 22 of 149
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931604
Page 23 of 149
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931605
Page 24 of 149
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931606
Page 25 of 149
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931607
Page 26 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931608
Page 27 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931609
Page 28 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931610
Page 29 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931611
Page 30 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931612
Page 31 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931613
Page 32 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931614
Page 33 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931615
Page 34 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931616
Page 35 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931617
Page 36 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931618
Page 37 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931619
Page 38 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931620
Page 39 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931621
Page 40 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Fever  Oct/1/2020 1
0:00 NO
End Date Time:
Oct/2/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Myalgias  Oct/1/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:
UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Left axilla ad
enopathy Oct/1/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931622
Page 41 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Fever]
4.Start Date Time: Oct/1/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931623
Page 42 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931624
Page 43 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931625
Page 44 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Myalgias]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931626
Page 45 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931627
Page 46 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931628
Page 47 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Left axilla adenopathy]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931629
Page 48 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931630
Page 49 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931631
Page 50 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931632
Page 51 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931633
Page 52 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931634
Page 53 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931635
Page 54 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931636
Page 55 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931637
Page 56 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931638
Page 57 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931639
Page 58 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931640
Page 59 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931641
Page 60 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931642
Page 61 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931643
Page 62 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931644
Page 63 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931645
Page 64 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931646
Page 65 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931647
Page 66 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931648
Page 67 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931649
Page 68 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931650
Page 69 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931651
Page 70 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931652
Page 71 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931653
Page 72 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931654
Page 73 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931655
Page 74 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/29/2020
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931656
Page 75 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931657
Page 76 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931658
Page 77 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormSep-11-2020 08:45:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931659
Page 78 of 149
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-10-2021 13:41:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Fried  Approved Nov-04-2020 15:09:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidFried, 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.
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931660
Page 79 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020
08:44:29
(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-11-2020
08:44:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931661
Page 80 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020
08:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/10/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931662
Page 81 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020
08:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11241207Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020
08:44:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1966Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020
08:45:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931663
Page 82 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-11-2020
08:45:14
(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-11-2020
08:45:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931664
Page 83 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
08:45:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931665
Page 84 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020
08:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020
08:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020
08:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931666
Page 85 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020
08:50:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Acid Ref
lux
Start Date: UNK/U
NK/199
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020
08:50:58
(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-11-2020
08:50:58
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Acid RefluxInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931667
Page 86 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-11-2020
08:50:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020
08:50:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-11-2020
08:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Anxiety
Start Date
:UNK/UN
K/1996Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931668
Page 87 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date
:
UNK/U
NK/200
0
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931669
Page 88 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020
08:51:28
(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-11-2020
08:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020
08:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020
08:51:28ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931670
Page 89 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2000
1.c
Date Location User Value Reason
Sep-11-2020
09:15:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Rhinitis
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931671
Page 90 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:15:23
(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-11-2020
09:15:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RhinitisInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-11-2020
09:15:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-11-2020
09:15:23ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931672
Page 91 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931673
Page 92 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
220.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931674
Page 93 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.5Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.8Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931675
Page 94 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931676
Page 95 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
08:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931677
Page 96 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020
08:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020
08:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
87187Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931678
Page 97 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
08:48:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
08:48:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
08:48:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
08:48:12
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931679
Page 98 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
08:48:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
08:48:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9608Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
08:48:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9608Initial Entry
5.b
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931680
Page 99 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-11-2020
08:48:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMNV8
JInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
08:48:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNV8JInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020
08:48:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMNV8
KInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
08:48:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNV8KInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931681
Page 100 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
08:48:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
08:48:58
(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-11-2020
08:49:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
08:48:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931682
Page 101 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
08:48:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
08:49:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9609Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
08:49:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9609Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931683
Page 102 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931684
Page 103 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 15:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
08:47:46
(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-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931685
Page 104 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
08:47:46
(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-11-2020
08:47:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931686
Page 105 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020
08:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931687
Page 106 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
14:59:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931688
Page 107 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:97.5
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931689
Page 108 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.a Temperature:
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020
15:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931690
Page 109 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
15:00:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
15:00:16
(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-01-2020
09:20:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-01-2020
05:13:02
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931691
Page 110 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
15:00:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
15:00:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
09:20:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP55H
VInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931692
Page 111 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-01-2020
09:20:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP55HVInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931693
Page 112 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931694
Page 113 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 13:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020
15:02:57
(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-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0931695
Page 114 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020
15:02:57
(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-30-2020
15:02:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931696
Page 115 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020
16:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931697
Page 116 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
16:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
16:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
16:14:06
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931698
Page 117 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-29-2020
16:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP55M
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP55MHInitial Entry
5.b
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931699
Page 118 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-29-2020
16:14:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMNVK
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
16:14:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNVKCInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
16:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMNVK
DInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
16:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNVKDInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931700
Page 119 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
08:54:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/11/2021Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931701
Page 120 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
08:54:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
08:54:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
08:55:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
08:54:51
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931702
Page 121 of 149
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
08:54:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
08:55:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP55SVInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
08:55:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP55SVInitial Entry
5.b
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931703
Page 122 of 149
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-12-2021
09:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFHPJInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
09:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSFHPJInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
09:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSFHP
KInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
09:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSFHPKInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931704
Page 123 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-02-2020
16:14:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-02-2020
13:17:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edTranscription
Error
Nov-02-2020
13:17:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Transcription
Error
Nov-02-2020
12:00:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened As per CRF
guidelines, the
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931705
Page 124 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
EOT to match
the date the
Visit 3.
Sep-30-2020
15:12:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020
15:12:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020
15:12:48
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931706
Page 125 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931707
Page 126 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931708
Page 127 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931709
Page 128 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931710
Page 129 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020
16:19:39
(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-29-2020
16:19:39
(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-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931711
Page 130 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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).
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931712
Page 131 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-29-2020
16:19:39
(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-29-2020
16:19:39
(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-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931713
Page 132 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020
16:19:39
(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-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931714
Page 133 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-29-2020
16:19:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931715
Page 134 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020
16:23:41
(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-29-2020
16:23:41
(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
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MyalgiasInitial Entry
4. Start Date Time:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931716
Page 135 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931717
Page 136 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-29-2020
16:23:41
(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-29-2020
16:23:41
(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-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931718
Page 137 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020
16:23:41
(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-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931719
Page 138 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020
16:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931720
Page 139 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020
16:27:17
(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-29-2020
16:27:17
(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
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Left axilla adenopathyInitial Entry
4. Start Date Time:
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931721
Page 140 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931722
Page 141 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-29-2020
16:27:17
(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-29-2020
16:27:17
(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
Nov-04-2020
07:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Nov-03-2020
16:44:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931723
Page 142 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
Nov-03-2020
16:44:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
Nov-02-2020
00:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please
complete this
item. Thank
you.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931724
Page 143 of 149
***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: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931725
Page 144 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
13:41:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/1/2021Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931726
Page 145 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-10-2021
13:44:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible and NOT c
onfirmed to have r
eceived only place
bo at Vaccination 1
/2Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931727
Page 146 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-10-2021
13:41:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021
13:41:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931728
Page 147 of 149
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-30-2020
15:12:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-11-2020
08:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-11-2020
08:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-02-2020
13:17:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Transcription
Error
Sep-30-2020
15:12:48ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931729
Page 148 of 149
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-11-2020
08:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-11-2020
08:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931730
Page 149 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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1. Casebook Signature
Date Location User Value Reason
Nov-04-2020
15:06:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
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leInitial Entry
090177e196ae3002\Final\Final On: 01-Apr-2021 03:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931731