Document text
Page 1 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970453
Page 2 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/22/2020
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970454
Page 3 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10971017]
2.Birth Date: 1943
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:
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970455
Page 4 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/22/2020
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970456
Page 5 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970457
Page 6 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970458
Page 7 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: Jun/29/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar Radiculopathy]
Start Date: Feb/4/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: Apr/15/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Back Pain1]
Start Date: Oct/1/2018
Ongoing: YES
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970459
Page 8 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Neuropathy]
Start Date: Oct/1/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Impotence]
Start Date: Apr/3/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mechanical Heart valve Replacement]
Start Date: Apr/3/2018
Ongoing: NO
End Date:
Apr/3/2018
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Apr/3/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Essential Hypertension]
Start Date: Apr/3/2018
Ongoing: YES
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970460
Page 9 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/22/2020
2.Weight: [164.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [22.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970461
Page 10 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/22/2020
2.Randomization Number: [237076]
3.Randomization Group: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970462
Page 11 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6B9B]
5.bSample ID [BN6B9K]
5.cSample ID [BN6B9L]
5.dSample ID [BL9XJL]
5.eSample ID [BL9XJM]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970463
Page 12 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6B94]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970464
Page 13 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/22/2020 11:48
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970465
Page 14 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970466
Page 15 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970467
Page 16 of 436
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970468
Page 17 of 436
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970469
Page 18 of 436
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970470
Page 19 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BN6B3W]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970471
Page 20 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/15/2020 13:37
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970472
Page 21 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970473
Page 22 of 436
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970474
Page 23 of 436
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970475
Page 24 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BL9XCR]
5.bSample ID [BL9XCS]
5.cSample ID [BN6BK6]
5.dSample ID [BN6BK8]
5.eSample ID [BN6BK7]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970476
Page 25 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970477
Page 26 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/17/2020
2.Date of First Symptom Started: Oct/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970478
Page 27 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Symptoms - Other
5.aSymptoms - Other Text: [Confusion]
5.bSymptoms - Other Text: [loss of appetite]
5.cSymptoms - Other Text: [Nausea]
5.dSymptoms - Other Text: [Frequent urination]
5.eSymptoms - Other Text: [acute encephalopathy]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970479
Page 28 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/19/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970480
Page 29 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/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 Comments
7.Test Result: POSITIVE
8Comments/Findings/Details [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970481
Page 30 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[no sample collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970482
Page 31 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BPVC4Y]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970483
Page 32 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970484
Page 33 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Oct/19/2020 NO
Discharge Date:
Nov/1/2020
Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970485
Page 34 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Oct/19/2020
4.Ongoing? NO
Discharge Date:
Nov/1/2020
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970486
Page 35 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970487
Page 36 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970488
Page 37 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 Pneumonia]
Date of Diagnosis:
Oct/19/2020
3.Toxicity Grade: 3
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970489
Page 38 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinic
al Event:Subcategory of Clinical EventDiagnosis Obtain
edToxicity
GradeForm Instan
ce
1. DELETED SEVERE COVID-1
9 ILLNESS SIGNIFICANT ACUTE NEUROL
OGIC DYSFUNCTION YES
Diagnosis:
Acute Encepha
lopathy
Start Date:
Oct/19/2020
Ongoing?:
NO
End Date:
Nov/1/2020
3 Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970490
Page 39 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[Acute Encephalopathy ]
Start Date:
Oct/19/2020
Ongoing?:
NO
End Date:
Nov/1/2020
4.Toxicity Grade: 3
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970491
Page 40 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970492
Page 41 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970493
Page 42 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970494
Page 43 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970495
Page 44 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970496
Page 45 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970497
Page 46 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970498
Page 47 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970499
Page 48 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970500
Page 49 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970501
Page 50 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970502
Page 51 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970503
Page 52 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970504
Page 53 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970505
Page 54 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970506
Page 55 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970507
Page 56 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970508
Page 57 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970509
Page 58 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970510
Page 59 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970511
Page 60 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Oct/19/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Left upper lobe infiltrate.
Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970512
Page 61 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/19/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Left upper lobe infiltrate.]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970513
Page 62 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970514
Page 63 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
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 [BPVC75]
5.bSample ID [BPVC76]
5.cSample ID [ ]
5.dSample ID [BL9XSH]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970515
Page 64 of 436
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/17/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/17/2020
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970516
Page 65 of 436
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/17/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970517
Page 66 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970518
Page 67 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970519
Page 68 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970520
Page 69 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970521
Page 70 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 Acute encephalopathy Oct/18/2020 21
:40 YES Repeating
Pages
2. ADVERSE
EVENT 2 non traumatic retroperit
oneal hematoma Nov/13/2020 U
NK:UNK NO
End Date Time:
Nov/15/2020 UNK:
UNK
Repeating
Pages
3. ADVERSE
EVENT 3 urinary tract infection Sep/19/2020 U
NK:UNK NO
End Date Time:
Nov/1/2020 UNK:
UNK
Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970522
Page 71 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Acute encephalopathy ]
4.Start Date Time: Oct/18/2020 21:40
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).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:
[COVID 19 and UTI and OPiod use ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970523
Page 72 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970524
Page 73 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[non traumatic retroperitoneal hematoma]
4.Start Date Time: Nov/13/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 UNK:UNK
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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970525
Page 74 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020453104]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970526
Page 75 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[urinary tract infection]
4.Start Date Time: Sep/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/1/2020 UNK:UNK
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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970527
Page 76 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970528
Page 77 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970529
Page 78 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970530
Page 79 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970531
Page 80 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: //
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970532
Page 81 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970533
Page 82 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970534
Page 83 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970535
Page 84 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970536
Page 85 of 436
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1.PACKED RBC Nov/13/2020 Repeating Pages
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970537
Page 86 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: PACKED RBC
2.Date of Transfusion: Nov/13/2020
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970538
Page 87 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970539
Page 88 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970540
Page 89 of 436
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970541
Page 90 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970542
Page 91 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970543
Page 92 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970544
Page 93 of 436
***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, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970545
Page 94 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970546
Page 95 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970547
Page 96 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970548
Page 97 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970549
Page 98 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970550
Page 99 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970551
Page 100 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970552
Page 101 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [BP2RT2]
5.bSample ID [BP2RT3]
5.cSample ID [BP2RT4]
5.dSample ID [BHGTDW]
5.eSample ID [BHGTDX]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970553
Page 102 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2RSP]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970554
Page 103 of 436
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 13:27
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970555
Page 104 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970556
Page 105 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BP2RZR]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970557
Page 106 of 436
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/8/2021 12:33
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
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970558
Page 107 of 436
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970559
Page 108 of 436
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [Subject has nothing new to report.]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970560
Page 109 of 436
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970561
Page 110 of 436
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970562
Page 111 of 436
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970563
Page 112 of 436
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970564
Page 113 of 436
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970565
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Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
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090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970566
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Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
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(b) (4)
FDA-CBER-2021-5683-0970567
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***Confidential***
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Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Mar-12-2021 09:43:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970568
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Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-25-2020 17:20:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970569
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-30-2020 08:25:33 (UTC-05:00) Eastern
Time (US & Canada)NALT Unknown
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970570
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***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 10:40:20 (UTC-05:00) Eastern
Time (US & Canada)
3Nov-19-2020 16:50:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
3Nov-18-2020 09:33:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970571
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970572
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970573
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970574
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970575
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970576
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970577
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-17-2020 15:48:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970578
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970579
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970580
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970581
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970582
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970583
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970584
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970585
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970586
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970587
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970588
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970589
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970590
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970591
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970592
Page 141 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970593
Page 142 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0970594
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970595
Page 144 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970597
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970600
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970601
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970603
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970604
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970605
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970606
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970607
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970608
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970609
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970610
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:52:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970611
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970612
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970613
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970614
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970615
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970616
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970617
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970618
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970619
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970620
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970621
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970622
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970623
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970624
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970625
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970626
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970627
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970629
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970631
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970632
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970633
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970634
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970635
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970636
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970637
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970638
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970639
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970640
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970641
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970642
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970647
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970648
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970652
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970654
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970655
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:53:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970656
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970657
Page 206 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970658
Page 207 of 436
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970659
Page 208 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970660
Page 209 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970661
Page 210 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-17-2020 15:53:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970662
Page 211 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:54:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970663
Page 212 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:54:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970664
Page 213 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-17-2020 15:54:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970665
Page 214 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:54:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970666
Page 215 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:54:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970667
Page 216 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-17-2020 15:54:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970668
Page 217 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-17-2020 15:54:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970669
Page 218 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970670
Page 219 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970671
Page 220 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970672
Page 221 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970673
Page 222 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970674
Page 223 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970675
Page 224 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-17-2020 15:55:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970676
Page 225 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormJan-18-2021 14:40:18 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970677
Page 226 of 436
***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, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Mar-12-2021 09:43:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-12-2021 07:48:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Mar-11-2021 15:38:26 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 13:53:14 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970678
Page 227 of 436
***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, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Tom
Christensen Approved Mar-09-2021 16:56:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-09-2021 16:52:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Mar-09-2021 14:20:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-09-2021 08:13:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Mar-09-2021 07:38:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970679
Page 228 of 436
***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, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-08-2021 14:18:07 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Feb-24-2021 16:21:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-08-2021 14:14:25 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Jan-20-2021 20:34:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970680
Page 229 of 436
***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, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
N/A Dec-04-2020 12:59:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Dec-02-2020 20:11:50 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-18-2020 09:33:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Nov-17-2020 16:37:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 17:38:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970681
Page 230 of 436
***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, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Tom
Christensen Approved Nov-16-2020 17:20:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 10:54:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Oct-22-2020 16:13:23 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970682
Page 231 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020 17:19:44
(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-25-2020 17:19:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970683
Page 232 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 17:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/22/2020Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970684
Page 233 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-22-2020 12:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10971017Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-22-2020 12:59:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 17:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 17:20:11
(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-25-2020 17:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970685
Page 234 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 17:20:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970686
Page 235 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020 17:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 17:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 17:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970687
Page 236 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 17:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Osteoarthrit
is
Start Date: Jun/29/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:23:08
(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-25-2020 17:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoarthritisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 17:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/29/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 17:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970688
Page 237 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-25-2020 17:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Lumbar Radicul
opathy
Start Date: Feb/4/2019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:23:37
(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-25-2020 17:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Lumbar RadiculopathyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 17:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 17:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-25-2020 17:23:59
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970689
Page 238 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) Medical History Ter
m:Gout
Start Date: Apr/15/201
9
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:23:59
(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
Aug-25-2020 17:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GoutInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 17:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/15/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 17:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-25-2020 17:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Chronic Back
Pain1Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970690
Page 239 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Start Date: Oct/1/2018
Ongoing: YES
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0970691
Page 240 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:24:30
(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 15:10:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-30-2020 08:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered It is due to Lumbar
radiculopathy
Aug-26-2020 10:52:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN - Please
review condition
CHRONIC BACK
PAIN and if a
diagnosis/etiology of
this pain is available,
please add to MH as
a separate entry.
Example - RA,OA,
Injury
Aug-25-2020 17:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic Back Pain1Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 17:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 17:24:30
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0970692
Page 241 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
1.e
Date Location User Value Reason
Aug-25-2020 17:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Neuropath
y
Start Date: Oct/1/2018
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NeuropathyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 17:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 17:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970693
Page 242 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-25-2020 17:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Impotence
Start Date: Apr/3/200
0
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ImpotenceInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 17:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/3/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 17:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-25-2020 17:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970694
Page 243 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Medical His
tory Term:Mechanical Heart va
lve Replacement
Start Date: Apr/3/2018
Ongoing: NO
End Date:
Apr/3/2018
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mechanical Heart valve Replace
mentInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020 17:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/3/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020 17:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/3/2018Initial Entry
1.h
Date Location User Value Reason
Aug-25-2020 17:26:46
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970695
Page 244 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) Medical History Te
rm:Hyperlipide
mia
Start Date: Apr/3/2018
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020 17:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/3/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020 17:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-25-2020 17:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Essential Hypert
ension
Start Date: Apr/3/2018Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970696
Page 245 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Essential HypertensionInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020 17:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/3/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020 17:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970697
Page 246 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
164.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.9Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0970698
Page 247 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 17:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0970699
Page 248 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 17:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 17:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
237076Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970700
Page 249 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 17:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 17:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 17:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 17:29:17
(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-25-2020 17:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 17:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B9BInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970701
Page 250 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 17:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B9BInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020 17:35:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B9KInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 17:35:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B9KInitial Entry
5.c
Date Location User Value Reason
Aug-25-2020 17:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B9LInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020 17:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B9LInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020 17:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XJLInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0970702
Page 251 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Aug-25-2020 17:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9XJLInitial Entry
5.e
Date Location User Value Reason
Aug-25-2020 17:36:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XJMInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020 17:36:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9XJMInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970703
Page 252 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 17:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 17:29:29
(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-25-2020 17:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 17:29:29
(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-25-2020 17:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 17:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B94Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970704
Page 253 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 17:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B94Initial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970705
Page 254 of 436
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 17:32:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 17:32:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 17:32:02
(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-25-2020 17:32:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020 11:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 17:32:02
(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-25-2020 17:32:02
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ebf\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0970706
Page 255 of 436
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Ve
…[truncated]