125742 S1 M5 CRF c4591001 1124 11241128

Document text

Page 1 of 352
***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: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931231
Page 2 of 352
***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: 11241128 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
Aug/31/2020
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931232
Page 3 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11241128]
2.Birth Date: 1953
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931233
Page 4 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931234
Page 5 of 352
***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: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931235
Page 6 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931236
Page 7 of 352
***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: 11241128 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:[High Blood Pressure]
Start Date: UNK/UNK/1980
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1970
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Crohn's Disease]
Start Date: UNK/UNK/1980
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931237
Page 8 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [225.0]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [29.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931238
Page 9 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [246375]
3.Randomization Group: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931239
Page 10 of 352
***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: 11241128 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:
Aug/31/2020
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 [BP95JX]
5.bSample ID [BPRVW4]
5.cSample ID [BPRVW5]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931240
Page 11 of 352
***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: 11241128 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:
Aug/31/2020
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 [BP95JY]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931241
Page 12 of 352
***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: 11241128 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: Aug/31/2020 14:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
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(b) (4)
FDA-CBER-2021-5683-0931242
Page 13 of 352
***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: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931243
Page 14 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931244
Page 15 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931245
Page 16 of 352
***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: 11241128 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/21/2020
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 [BP95SW]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931246
Page 17 of 352
***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: 11241128 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/21/2020 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931247
Page 18 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931248
Page 19 of 352
***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: 11241128 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/26/2020
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 [BP55L6]
5.bSample ID [BPRVBK]
5.cSample ID [BPRVBL]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931249
Page 20 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931250
Page 21 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/17/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931251
Page 22 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.aSymptoms - Other Text: Not Applicable
[ ]Comments
5.bSymptoms - Other Text: [stomach cramps]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931252
Page 23 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/19/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931253
Page 24 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/19/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931254
Page 25 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject unable to self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931255
Page 26 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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:
Jan/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SAMPLE DRAW ON 1/18/21-MOVED TO SWAB PFE PER DATA
MANAGEMENT]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZ5B8]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931256
Page 27 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931257
Page 28 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Dec/24/2020  NO
Discharge Date:
Dec/30/2020
 Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931258
Page 29 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/24/2020
4.Ongoing? NO
Discharge Date:
Dec/30/2020
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0931259
Page 30 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931260
Page 31 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0931261
Page 32 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/19/2020
3.Toxicity Grade: 3
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931262
Page 33 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931263
Page 34 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931264
Page 35 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Na
meCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.CLINICAL CH
EMISTRY South Count
y Hospital
100 Kenyon
Ave
Wakefield, R
I 02879 Dec/22/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 [ ] 
30  Alanine Aminotran
sferase_PX30 [ ] 
28  Aspartate Aminotra
nsferase_PX28 [ ] 
35  Alkaline Phosphata
se_PX35 52 
21  Bilirubin_PX21  0.8 
47  Blood Urea Nitroge
n_PX47 13 
48  Creatinine_PX48  1.00
 Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931265
Page 36 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Na
meCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 2.CLINICAL CH
EMISTRY South Count
y Hospital
100 Kenyon
Ave
Wakefield, R
I 02879 Dec/24/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 121.
9 
30  Alanine Aminotran
sferase_PX30 [ ] 
28  Aspartate Aminotra
nsferase_PX28 [ ] 
35  Alkaline Phosphata
se_PX35 45 
21  Bilirubin_PX21  0.8 
47  Blood Urea Nitroge
n_PX47 10 
48  Creatinine_PX48  0.76
 Repeating
Pages
 3.CLINICAL CH
EMISTRY South Count
y Hospital
100 Kenyon
Ave
Wakefield, R
I 02879 Dec/28/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 12.1
 
30  Alanine Aminotran
sferase_PX30 [ ] 
28  Aspartate Aminotra
nsferase_PX28 [ ] 
35  Alkaline Phosphata
se_PX35 44 
21  Bilirubin_PX21  0.8 
47  Blood Urea Nitroge
n_PX47 18 
48  Creatinine_PX48  0.75
 Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931266
Page 37 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/22/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931267
Page 38 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [52]
Not Done:
LNMT Low
[32]
High
[105]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.8]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931268
Page 39 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[8]
High
[26]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.00]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931269
Page 40 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [121.9]
Not Done:
LNMT Low
[0.0]
High
[10.0]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931270
Page 41 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [45]
Not Done:
LNMT Low
[32]
High
[105]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.8]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931271
Page 42 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [10]
Not Done:
LNMT Low
[8]
High
[26]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.76]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931272
Page 43 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/28/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [12.1]
Not Done:
LNMT Low
[0.0]
High
[10.0]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931273
Page 44 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [44]
Not Done:
LNMT Low
[32]
High
[105]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.8]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931274
Page 45 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [18]
Not Done:
LNMT Low
[8]
High
[26]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.75]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931275
Page 46 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.HEMATOLO
GY South County Ho
spital
100 Kenyon Ave
Wakefield, RI 02
879 Dec/28/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin_
PX1 12.4 
2  Hematocrit_
PX2 36.7 
3  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 285 
7  Leukocytes_
PX7 [ ] 
608  Neutrophils_
PX608 3.9 
609  Eosinophils_
PX609 0 
612  Monocytes_P
X612 8 
610  Basophils_P
X610 0 
611  Lymphocytes
_PX611 1.7 Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931276
Page 47 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 2.HEMATOLO
GY South County Ho
spital
100 Kenyon Ave
Wakefield, RI 02
879 Dec/22/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin_
PX1 14.0 
2  Hematocrit_
PX2 41..5
 
3  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 185 
7  Leukocytes_
PX7 5.3 
608  Neutrophils_
PX608 3.9 
609  Eosinophils_
PX609 0.0 
612  Monocytes_P
X612 0.4 
610  Basophils_P
X610 0.0 
611  Lymphocytes
_PX611 1.0 Repeating
Pages
 3.HEMATOLO
GY South County Ho
spital
100 Kenyon Ave
Wakefield, RI 02
879 Dec/24/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin_
PX1 13.0 
2  Hematocrit_
PX2 38.4 
3  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 167 
7  Leukocytes_
PX7 5.6 Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931277
Page 48 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
Sponsor-Define
d IdentifierTest:Res
ult:
608  Neutrophils_
PX608 4.2 
609  Eosinophils_
PX609 0.0 
612  Monocytes_P
X612 0.3 
610  Basophils_P
X610 0.0 
611  Lymphocytes
_PX611 1.0 
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931278
Page 49 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/28/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.4]
Not Done:
LNMT Low
[13.5]
High
[175]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.7]
Not Done:
LNMT Low
[40.00]
High
[52.0]
Unit
%
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931279
Page 50 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [285]
Not Done:
LNMT Low
[140]
High
[430]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931280
Page 51 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.9]
Not Done:
LNMT Low
[2.1]
High
[7.5]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[0]
High
[8]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [8]
Not Done:
LNMT Low
[2]
High
[12]
Unit
%
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931281
Page 52 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.7]
Not Done:
LNMT Low
[1.2]
High
[4.5]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931282
Page 53 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/22/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.0]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [41..5]
Not Done:
LNMT Low
[40.0]
High
[52.0]
Unit
%
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931283
Page 54 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [185]
Not Done:
LNMT Low
[140]
High
[430]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.3]
Not Done:
LNMT Low
[4.0]
High
[10.8]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931284
Page 55 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.9]
Not Done:
LNMT Low
[2.1]
High
[7.5]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.6]
Unit
10^6/cu mm
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.4]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931285
Page 56 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^6/cu mm
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.0]
Not Done:
LNMT Low
[1.2]
High
[4.5]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931286
Page 57 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [South County Hospital
100 Kenyon Ave
Wakefield, RI 02879]
3.Collection Date: Dec/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.0]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.4]
Not Done:
LNMT Low
[40.0]
High
[52.0]
Unit
%
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931287
Page 58 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [167]
Not Done:
LNMT Low
[140]
High
[430]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.6]
Not Done:
LNMT Low
[4.0]
High
[10.8]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931288
Page 59 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.2]
Not Done:
LNMT Low
[2.1]
High
[7.5]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.6]
Unit
10^6/cu mm
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.3]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931289
Page 60 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^6/cu mm
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.0]
Not Done:
LNMT Low
[1.2]
High
[4.5]
Unit
10^6/cu mm
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931290
Page 61 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Dec/24/2020 Record Identifier: Systolic: Diastolic:
1  158  90 Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931291
Page 62 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [158]
Diastolic: [90]
Respiratory Rate in
respirations/minute:[23]
Heart Rate in beats/minute: [91]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931292
Page 63 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Dec/24/2020 Record Identifier: Oxygen Saturation
1  88.0 Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931293
Page 64 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/24/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [88.0]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931294
Page 65 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931295
Page 66 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931296
Page 67 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931297
Page 68 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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.Start Date: //
6.Ongoing?
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931298
Page 69 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931299
Page 70 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931300
Page 71 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/18/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931301
Page 72 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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:
Jan/18/2021
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 [BNZSB7]
5.bSample ID [BPRVFB]
5.cSample ID [BPRVFC]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931302
Page 73 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931303
Page 74 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931304
Page 75 of 352
***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: 11241128 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931305
Page 76 of 352
***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: 11241128 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: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931306
Page 77 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Jan/18/2021Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: Not Applicable Comments
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931307
Page 78 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]Comments
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931308
Page 79 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Hair loss  Sep/UNK/2020 UNK:
UNK YES  Repeating
Pages
 2.ADVERSE EVE
NT 2  Covid 19  Dec/17/2020 UNK:U
NK YES  Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931309
Page 80 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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)[Hair loss]
4.Start Date Time: Sep/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[alopecia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931310
Page 81 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931311
Page 82 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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)[Covid 19]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931312
Page 83 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Covid 19 pandemic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020516903]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931313
Page 84 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931314
Page 85 of 352
***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: 11241128 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[ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931315
Page 86 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931316
Page 87 of 352
***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: 11241128 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: //
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931317
Page 88 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931318
Page 89 of 352
***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: 11241128 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?
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931319
Page 90 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931320
Page 91 of 352
***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: 11241128 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?
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931321
Page 92 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931322
Page 93 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931323
Page 94 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931324
Page 95 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11241128 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:
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931325
Page 96 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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?
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931326
Page 97 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931327
Page 98 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931328
Page 99 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931329
Page 100 of 352
***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: 11241128 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931330
Page 101 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931331
Page 102 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931332
Page 103 of 352
***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: 11241128 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: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931333
Page 104 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931334
Page 105 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/3/2021
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931335
Page 106 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931336
Page 107 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931337
Page 108 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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:
Feb/3/2021
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 [BNZ5DH]
5.bSample ID [BPRVHF]
5.cSample ID [BPRVHG]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931338
Page 109 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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:
Feb/3/2021
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 [BNZ5DK]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931339
Page 110 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 15:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931340
Page 111 of 352
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931341
Page 112 of 352
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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:
Feb/26/2021
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 [BP55PS]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931342
Page 113 of 352
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 12:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931343
Page 114 of 352
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931344
Page 115 of 352
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931345
Page 116 of 352
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931346
Page 117 of 352
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931347
Page 118 of 352
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931348
Page 119 of 352
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931349
Page 120 of 352
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931350
Page 121 of 352
***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: 11241128 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/26/2020
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931351
Page 122 of 352
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931352
Page 123 of 352
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11241128 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
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931353
Page 124 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-31-2020 15:36:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931354
Page 125 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aDec-28-2020 15:55:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931355
Page 126 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: DATE OF VISIT - REPEAT SWAB - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-12-2021 14:41:18 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931356
Page 127 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-16-2021 17:43:21 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
Not Applicable
FormFeb-12-2021 14:42:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931357
Page 128 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-16-2021 17:43:21 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931358
Page 129 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Feb-16-2021 17:43:21 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
Not Applicable
2Feb-12-2021 14:44:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931359
Page 130 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-16-2021 17:43:21 (UTC-05:00) Eastern
Time (US & Canada) )Not Applicable
Not Applicable
3Feb-12-2021 14:45:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931360
Page 131 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-16-2021 17:43:21 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931361
Page 132 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aFeb-12-2021 14:46:06 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931362
Page 133 of 352
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 11:08:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931363
Page 134 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11241128 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 Dec-22-2020 09:47:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Fried  Approved Nov-03-2020 15:10:14 (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.
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931364
Page 135 of 352
***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: 11241128 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
Aug-31-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931365
Page 136 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 15:26:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931366
Page 137 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 15:25:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11241128Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 15:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 15:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 15:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 15:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931367
Page 138 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 15:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931368
Page 139 of 352
***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: 11241128 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
Aug-31-2020 15:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 15:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 15:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0931369
Page 140 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 15:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:High Blood Pr
essure
Start Date: UNK/UNK/19
80
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 15:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 15:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
High Blood PressureInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 15:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 15:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931370
Page 141 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b
Date Location User Value Reason
Aug-31-2020 15:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Gastroesophageal
reflux disease
Start Date: UNK/UNK/1970
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 15:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 15:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 15:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 15:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931371
Page 142 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-31-2020 15:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Crohn's Disea
se
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931372
Page 143 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 15:43:08
(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-03-2020 18:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Carlos Linn Query 1: Closed Response satisfies
query
Sep-03-2020 09:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No systemic steroid,
immunosuppressant,
or biological use for
this subject
Sep-03-2020 09:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Carlos Linn Query 1: Opened Any concern of
autoimmune disease,
systemic steroid use?
immunosuppressants?
or biological use for
this subject?
Aug-31-2020 15:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Crohn's DiseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 15:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 15:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931373
Page 144 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-31-2020 15:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Depression
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 15:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 15:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 15:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 15:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931374
Page 145 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
225.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
73.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.7Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931375
Page 146 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 15:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931376
Page 147 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 15:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 15:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
246375Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931377
Page 148 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 15:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 15:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 15:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 15:38:23
(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.
Aug-31-2020 15:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 08:13:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95JXTranscription Error
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0931378
Page 149 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-01-2020 10:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95JYTranscription Error
Aug-31-2020 15:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95JXInitial Entry
5.a Sample ID
Date Location User ValueReason
Sep-10-2020
02:36:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedPer site confirmation
Sep-09-2020
08:13:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredTranscription Error
Sep-09-2020
08:13:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP95J
XTranscription Error
Sep-09-2020
01:39:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM1: The page for
Nasal Swab is
unfreeze. Per
response please
consider to update
the data as
appropriate. Else
clarify.
Sep-08-2020
10:22:50
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Query
2: Ans
weredfrozen need to
unfreeze to change
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931379
Page 150 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
Sep-08-2020
03:40:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Saumitra Dubey Query
2: Op
enedLIMS Query: As per
the lab, Sample ID -
BP95JY received for
Nasal Swab sample
and not for Serum
sample. Please check
and correct the data,
else clarify.
Sep-01-2020
14:38:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-01-2020
10:53:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-01-2020
10:53:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP95J
YTranscription Error
Aug-31-2020
20:29:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4427376;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-31-2020
15:39:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP95J
XInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931380
Page 151 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b
Date Location User Value Reason
Aug-31-2020 15:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRVW4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 15:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRVW4Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020 15:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRVW5Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 15:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRVW5Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931381
Page 152 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 15:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 15:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 15:40:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 15:40:37
(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.
Aug-31-2020 15:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 08:13:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95JYTranscription Error
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931382
Page 153 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-31-2020 15:40:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95JXInitial Entry
5.a Sample ID
Date Location User ValueReason
Sep-10-2020
17:20:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-10-2020
10:31:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredBarcode for subject
11241123 has been
updated.
Sep-10-2020
05:24:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW4650598;The
barcode BP95JY is
recorded for two
subjects 11241123
and 11241128. Please
review and update as
appropriate.
Sep-09-2020
08:13:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP95J
YTranscription Error
Sep-01-2020
14:43:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-01-2020
14:38:31
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931383
Page 154 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time
(US &
Canada)
Sep-01-2020
10:53:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredupdated
Sep-01-2020
10:53:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredupdated
Sep-01-2020
06:46:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW4427477;This
Barcode BP95JX
appears to be already
recorded within the
study for this subject.
Please review and
update as
appropriate.
Aug-31-2020
20:29:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4427377;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-31-2020
15:40:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP95J
XInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931384
Page 155 of 352
***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: 11241128 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
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020 14:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931385
Page 156 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931386
Page 157 of 352
***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: 11241128 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
Aug-31-2020 15:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931387
Page 158 of 352
***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: 11241128 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-22-2020 12:56:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931388
Page 159 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931389
Page 160 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-22-2020 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931390
Page 161 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 12:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 12:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 12:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 12:56:53
(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-22-2020 12:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 12:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP95SWInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931391
Page 162 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 12:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP95SWInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931392
Page 163 of 352
***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: 11241128 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-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 14:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931393
Page 164 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-22-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931394
Page 165 of 352
***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: 11241128 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-26-2020 15:47:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931395
Page 166 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 15:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 15:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 15:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 15:47:42
(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.
Oct-26-2020 15:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 15:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP55L6Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931396
Page 167 of 352
***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: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 15:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP55L6Initial Entry
5.b
Date Location User Value Reason
Oct-26-2020 15:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRVBKInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 15:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRVBKInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 15:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRVBLInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 15:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRVBLInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931397
Page 168 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 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 16:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Deleted Close Auto Query
Feb-10-2021 16:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Jan-05-2021 01:36:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-04-2021 09:00:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated what could
be updated
Jan-04-2021 08:42:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Jan-04-2021 01:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-31-2020 14:13:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per
query
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931398
Page 169 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-31-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-23-2020 07:54:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review
and complete
‘Health Care
Utilization form' at
this visit. Thank
you.
Dec-23-2020 00:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-22-2020 09:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-22-2020 09:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931399
Page 170 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
update as
appropriate.
Dec-22-2020 09:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-22-2020 09:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931400
Page 171 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931401
Page 172 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931402
Page 173 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.c Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931403
Page 174 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:YESInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.g
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931404
Page 175 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931405
Page 176 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.h Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-22-2020 09:49:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-28-2020 15:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:Not Applicab
leInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931406
Page 177 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-28-2020 15:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other:Transcription Error
Dec-22-2020 09:49:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Oth
er:SORE THRO
ATInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-29-2020 12:50:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-28-2020 15:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Dec-28-2020 15:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-28-2020 15:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-28-2020 12:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Please enter
sore throat under 4g.
Dec-22-2020 09:49:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SORE THROATInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020 09:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:stomach cram
psInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931407
Page 178 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-23-2020 09:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
stomach crampsInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931408
Page 179 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931409
Page 180 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/19/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931410
Page 181 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7. Test Result:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-22-2020 09:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UnknownInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931411
Page 182 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 09:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 09:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 10:49:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-11-2021 11:08:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject never sent
in swab
Jan-07-2021 22:11:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Please query
open until resolved
Jan-04-2021 09:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Jan-04-2021 09:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Dec-29-2020 10:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Per SAE
report (#
2020516903) the
subjected entered in
the ediary on 21
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931412
Page 183 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec 2020 that he
had COVID-19
symptoms and was
instructed to collect
a self-swab at
home. Please obtain
a nasal swab as
soon as possible
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-04-2021 09:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject unable to self swabInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931413
Page 184 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-31-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-31-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 11:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-10-2021 23:09:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Closed Response satisfies
query
Feb-10-2021 16:28:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Answered SEE COMMENT
Feb-10-2021 16:28:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Deleted Close Auto Query
Feb-10-2021 16:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-10-2021 16:27:19
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened Date of Collection
18/Jan/2021 is
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931414
Page 185 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) different from Date
of Visit 21/Dec
/2020. Please
review and update
as appropriate, else
clarify.
Feb-10-2021 16:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/18/2021Changed
Information
Feb-10-2021 16:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Feb-10-2021 16:22:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Feb-10-2021 16:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened 'Sample Collected?'
is marked as No
and 'If no sample
was collected or
sample was not
collected according
to protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Feb-10-2021 16:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to
"Sample
Collected?" is No,
but Barcodes are
present on the page.
Feb-10-2021 16:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-10-2021 16:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged
Information
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931415
Page 186 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-09-2021 14:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thank you. The
COV RSWAB can
now be marked as
an erroneous visit
and other data for
that visit can be
marked at not
applicable.
Feb-08-2021 14:11:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-08-2021 11:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered confirmed
Feb-08-2021 11:39:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Feb-08-2021 11:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-08-2021 11:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection
18/Jan/2021 is
different from Date
of Visit 21/Dec
/2020. Please
review and update
as appropriate, else
clarify.
Feb-08-2021 11:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-08-2021 11:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/18/2021Changed
Information
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931416
Page 187 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-28-2021 15:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thanks for the
query answer. Per
guidance from
project
management,
please move the
data from the COV
RSWAB to this
eCRF.
Jan-27-2021 15:26:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Collected at the
Convalescent visit
Jan-27-2021 13:05:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per COVID
convalescent
source, subject
returned on
18Jan2021 and was
still symptomatic.
Therefore, a nasal
swab was collected
on site. Please
reconcile eCRF and
enter barcode.
Dec-31-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-10-2021 16:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SAMPLE DRAW ON 1/18/21-
MOVED TO SWAB PFE PER
DATA MANAGEMENTChanged
Information
Feb-10-2021 16:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SAMPLE DRAW AT THIS VI
SIT-MOVED TO SWAB PFE
PER DATA MANAGEMENTInitial Entry
Feb-08-2021 11:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931417
Page 188 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-31-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hospitalizedInitial Entry
5.a
Date Location User Value Reason
Feb-10-2021 16:28:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNZ5B8Initial Entry
Feb-10-2021 16:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Feb-10-2021 16:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
(DELETED)
Feb-10-2021 16:22:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Feb-08-2021 11:39:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNZ5B8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-11-2021
00:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edResponse satisfies
query
Feb-10-2021
16:28:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
BNZ5
B8Initial Entry
Feb-10-2021
16:27:40ACV0PFEINFP6000  Data E
ntry:Transcription Error
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931418
Page 189 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time
(US &
Canada)
Feb-10-2021
16:23:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:Transcription Error
(DELETED)
Feb-10-2021
16:22:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:Transcription Error
Feb-10-2021
16:22:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredWAS TOLD TO
ENTER THIS
SAMPLE IN
COVID VISIT-
ALTHOUGH IT
WAS DRAWN AT
THIS VISIT
Feb-08-2021
15:36:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7188828;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Feb-08-2021
11:39:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
BNZ5
B8Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0931419
Page 190 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contacts
:
1Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931420
Page 191 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931421
Page 192 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0931422
Page 193 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-08-2021 14:24:13 ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: Did subject
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931423
Page 194 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)receive oxygen or
have imaging
performed? If so,
please complete
RESP TX and
IMAGING CRFs.
Mar-08-2021 14:08:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated and medical
records sent
Mar-02-2021 08:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: Pending
receipt of medical
records.
Mar-01-2021 16:34:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered cannot specify as
records have not
been received
Feb-26-2021 08:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: Please specify
when this data will
be entered.
Feb-25-2021 15:28:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No hospitalization
information at this
time
Feb-18-2021 14:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: As this subject
was hospitalized,
please make every
effort to request
medical records and
complete RESP TX,
ILL SEVERE, LAB
CHEM, LAB HEM,
VITALS COV,
PULSE OX,
OXYGEN,
VASOPRESS, and
IMAGING CRFs, as
applicable.
Feb-16-2021 09:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No additional
information
available
Jan-27-2021 13:18:53
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Reissued:Opened Clin: No changes
seen. Please enter on
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0931424
Page 195 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Queries
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) the CRF form any
available
information
(hospitalization,
vital signs, pulse
oxymet, respiratory
treatment, lab
results, imaging…).
Please make every
effort to obtain these
information.
Jan-27-2021 09:04:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-22-2021 13:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Query: As
this subject was
hospitalized, please
enter on the CRF
form any available
information
(hospitalization,
vital signs, pulse
oxymet, respiratory
treatment, lab
results, imaging…).
Please make every
effort to obtain these
information.
Dec-31-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in inten
sive care due to potential CO
VID-19 illness?
NOInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931425
Page 196 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Jan-27-2021 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931426
Page 197 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Jan-27-2021 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Jan-27-2021 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Jan-27-2021 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/24/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Jan-27-2021 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Dec/30/2020Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931427
Page 198 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-22-2020 09:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-29-2020 12:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-28-2020 15:54:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-28-2020 15:54:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
COVID-19
Date of Diagnosis:
Dec/19/2020Transcription Error
Dec-28-2020 12:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Please
consider updating
date of diagnosis to
match collection
date of 19Dec2020
of positive local
swab.
Dec-22-2020 09:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
COVID-19Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0931428
Page 199 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Diagnosis:
Dec/20/2020
3. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020 09:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931429
Page 200 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931430
Page 201 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
South County Hospital
100 Kenyon Ave
Wakefield, RI 02879Initial Entry
3. Collection Date:
Date Location User Value Reason
Mar-08-2021 13:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-08-2021 13:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020Transcription Error
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection Date,
22/Dec/2021 is a
future date relative
to when it was
entered on 08/Mar
/2021. Please
correct.
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-08-2021 13:33:54 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931431
Page 202 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) BLOOD
5.a
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931432
Page 203 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:30
Test:: Alanine Aminotr
ansferase_PX30
Result::
Not Done:: NOT DONE
Lab Normal R
ange:Initial Entry
5.b Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Not Done:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:28
Test:: Aspartate Aminot
ransferase_PX28
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931433
Page 204 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Normal R
ange:
5.c Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aspartate Aminotransferase_PX2
8Initial Entry
5.c Not Done:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:35
Test:: Alkaline Phosph
atase_PX35
Result:: 52
Not Done::Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931434
Page 205 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Normal Ra
nge:Low
32
High
105
Unit
U/L
5.d Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
52Initial Entry
5.d LNMT
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
32
High
105
Unit
U/LInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931435
Page 206 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.e
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:21
Test:: Bilirubin_P
X21
Result:: 0.8
Not Done::
Lab Normal Range: Low
0.3
High
1.2
Unit
mg/dLInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931436
Page 207 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.e Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0.8Initial Entry
5.e LNMT
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.3
High
1.2
Unit
mg/dLInitial Entry
5.f
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:47
Test:: Blood Urea Nitr
ogen_PX47Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931437
Page 208 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Result:: 13
Not Done::
Lab Normal Ra
nge:Low
8
High
26
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931438
Page 209 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.f Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
5.f LNMT
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
8
High
26
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:48
Test:: Creatinine_P
X48Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931439
Page 210 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Result:: 1.00
Not Done::
Lab Normal Range
:Low
0.6
High
1.2
Unit
mg/dL
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931440
Page 211 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.g Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1.00Initial Entry
5.g LNMT
Date Location User Value Reason
Mar-08-2021 13:33:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.6
High
1.2
Unit
mg/dLInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931441
Page 212 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 20-Feb-2021 02:26 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931442
Page 213 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 20-Feb-2021 02:26 Form Status:
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-08-2021 14:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931443
Page 214 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
South County Hospital
100 Kenyon Ave
Wakefield, RI 02879Initial Entry
3. Collection Date:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/24/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329
Result:: 121.9
Not Done::Initial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931444
Page 215 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Normal Ra
nge:Low
0.0
High
10.0
Unit
mg/L
5.a Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
121.9Initial Entry
5.a LNMT
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.0
High
10.0
Unit
mg/LInitial Entry
090177e196ae3003\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931445
Page 216 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1124 Site Name: (1124) Omega Medical Research
Subject No: 11241128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:30
Test:: Alanine Aminotr
ansferase_PX30
Result::
Not Done:: NOT DONE
Lab Normal R
ange:Initial Entry
5.b Sponsor ID:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Not Done:
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:28Initial Entry
090177e196ae3003\Final\F
…[truncated]