Document text
Page 1 of 406
***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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971776
Page 2 of 406
***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: 10971061 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/28/2020
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971777
Page 3 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10971061]
2.Birth Date: 1953
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971778
Page 4 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971779
Page 5 of 406
***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: 10971061 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 Done
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Done
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971780
Page 6 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971781
Page 7 of 406
***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: 10971061 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:[Peripheral Vascular Disease]
Start Date: Feb/18/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Chronic depression]
Start Date: Apr/22/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[COPD]
Start Date: Mar/23/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Fibromyalgia]
Start Date: Mar/23/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Degenerative Lumbar disc]
Start Date: Mar/23/2018
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Vit D deficiency]
Start Date: Mar/23/2018
Ongoing: YES
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971782
Page 8 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[ADHD]
Start Date: Mar/23/2018
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Anxiety]
Start Date: Mar/23/2020
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hyperlipidemia]
Start Date: Mar/23/2018
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypertension]
Start Date: Mar/23/2018
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Pulmonary Fibrosis]
Start Date: Dec/UNK/2015
Ongoing: YES
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971783
Page 9 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [135.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [22.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971784
Page 10 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971785
Page 11 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [244514]
3.Randomization Group: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971786
Page 12 of 406
***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: 10971061 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/28/2020
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 [BN69ZV]
5.bSample ID [BN69ZS]
5.cSample ID [BN69ZT]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971787
Page 13 of 406
***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: 10971061 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/28/2020
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 [BN6BDC]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971788
Page 14 of 406
***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: 10971061 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/28/2020 13:35
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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971789
Page 15 of 406
***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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971790
Page 16 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971791
Page 17 of 406
***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: 10971061 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971792
Page 18 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971793
Page 19 of 406
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971794
Page 20 of 406
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971795
Page 21 of 406
***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: 10971061 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/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 [BN6B4B]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971796
Page 22 of 406
***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: 10971061 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/17/2020 14:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971797
Page 23 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971798
Page 24 of 406
***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: 10971061 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971799
Page 25 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: RIGHT
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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971800
Page 26 of 406
***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: 10971061 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:
Nov/12/2020
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 [BPVCPH]
5.bSample ID [BPVCPJ]
5.cSample ID [BPVCPK]
5.dSample ID [BL9XR7]
5.eSample ID [BL9XR8]
5 fSample ID [BL9XR9]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971801
Page 27 of 406
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971802
Page 28 of 406
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971803
Page 29 of 406
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971804
Page 30 of 406
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971805
Page 31 of 406
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971806
Page 32 of 406
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971807
Page 33 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: 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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971808
Page 34 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/12/2020
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
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
Symptoms - Other
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971809
Page 35 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.Symptoms - Other Text: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971810
Page 36 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971811
Page 37 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971812
Page 38 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: 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: 10971061 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
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Patient was in hospital then went to stay with her daughter. We were unable to make
contact with her for a brief period of time.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971813
Page 39 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: 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: 10971061 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/12/2020Comments
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 [BPVCPF]
5.bSample ID [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971814
Page 40 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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: YES
Number of Visits or Contacts:
[1]
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?NO
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971815
Page 41 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971816
Page 42 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971817
Page 43 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO Comments
3.Toxicity Grade: 0 Comments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971818
Page 44 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971819
Page 45 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971820
Page 46 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined Id
entifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971821
Page 47 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971822
Page 48 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971823
Page 49 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971824
Page 50 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971825
Page 51 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable 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
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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971826
Page 52 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971827
Page 53 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971828
Page 54 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971829
Page 55 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971830
Page 56 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971831
Page 57 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971832
Page 58 of 406
***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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971833
Page 59 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971834
Page 60 of 406
***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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971835
Page 61 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971836
Page 62 of 406
***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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971837
Page 63 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971838
Page 64 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971839
Page 65 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971840
Page 66 of 406
***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: 10971061 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.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971841
Page 67 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971842
Page 68 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971843
Page 69 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10971061 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/11/2020
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 [BPVC70]
5.bSample ID [BPVC71]
5.cSample ID [BPVC72]
5.dSample ID [BL9XSF]
5.eSample ID [BL9XSG]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971844
Page 70 of 406
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971845
Page 71 of 406
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971846
Page 72 of 406
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971847
Page 73 of 406
***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: 10971061 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: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971848
Page 74 of 406
***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: 10971061 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:
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971849
Page 75 of 406
***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: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971850
Page 76 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVEN
T 1 Uremic encephalopat
hy Oct/22/2020 23:
58 NO
End Date Time:
Oct/25/2020 11:48
Repeating
Pages
2.ADVERSE EVEN
T 2 Acute kidney injury Oct/22/2020 23:
57 NO
End Date Time:
Oct/25/2020 11:48
Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971851
Page 77 of 406
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Uremic encephalopathy]
4.Start Date Time: Oct/22/2020 23:58
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/25/2020 11:48
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[uremic encaphalopathy due to AKI.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971852
Page 78 of 406
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020426230]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971853
Page 79 of 406
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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)[Acute kidney injury]
4.Start Date Time: Oct/22/2020 23:57
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/25/2020 11:48
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971854
Page 80 of 406
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020426230]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971855
Page 81 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971856
Page 82 of 406
***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: 10971061 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[ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971857
Page 83 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971858
Page 84 of 406
***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: 10971061 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: //
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971859
Page 85 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971860
Page 86 of 406
***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: 10971061 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?
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971861
Page 87 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971862
Page 88 of 406
***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: 10971061 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?
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971863
Page 89 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971864
Page 90 of 406
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971865
Page 91 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971866
Page 92 of 406
***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: 10971061 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:
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971867
Page 93 of 406
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971868
Page 94 of 406
***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: 10971061 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?
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971869
Page 95 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971870
Page 96 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971871
Page 97 of 406
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971872
Page 98 of 406
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971873
Page 99 of 406
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971874
Page 100 of 406
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10971061 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 [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971875
Page 101 of 406
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971876
Page 102 of 406
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971877
Page 103 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971878
Page 104 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971879
Page 105 of 406
***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: 10971061 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: [ ]
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971880
Page 106 of 406
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971881
Page 107 of 406
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10971061 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
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971882
Page 108 of 406
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10971061 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 Feb-24-2021 19:06:19 (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.
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971883
Page 109 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-28-2020 15:57:07 (UTC-05:00) Eastern Time
(US & Canada)Incomplete
Not Done
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971884
Page 110 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971885
Page 111 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971886
Page 112 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971887
Page 113 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971888
Page 114 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971889
Page 115 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971890
Page 116 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971891
Page 117 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971892
Page 118 of 406
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-02-2020 08:18:00 (UTC-05:00) Eastern Time
(US & Canada)subject stated they had a hysterectomy
Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971893
Page 119 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 16:37:39 (UTC-05:00) Eastern Time
(US & Canada)Subject had no signs or symptoms of COVID
Not Applicable
2Nov-24-2020 12:08:27 (UTC-05:00) Eastern Time
(US & Canada)Subject had no signs or symptoms of COVID
2Nov-23-2020 08:57:32 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-19-2020 16:40:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971894
Page 120 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-20-2020 10:48:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971895
Page 121 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4.aNov-20-2020 10:49:08 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971896
Page 122 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
FormNov-24-2020 12:39:55 (UTC-05:00) Eastern Time
(US & Canada)done
FormNov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormNov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
FormNov-24-2020 12:33:29 (UTC-05:00) Eastern Time
(US & Canada)No test done for COVID
090177e196ae3ebe\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-2021-5683-0971897
Page 123 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Nov-17-2020 12:21:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971898
Page 124 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2Nov-20-2020 10:47:53 (UTC-05:00) Eastern Time
(US & Canada)no COVID testing done according to hospital
records.
2Nov-19-2020 16:43:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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-2021-5683-0971899
Page 125 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
3Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
3Nov-20-2020 10:50:49 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971900
Page 126 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ebe\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-2021-5683-0971901
Page 127 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
5Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
5Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ebe\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-2021-5683-0971902
Page 128 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
6Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
6Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
6Nov-17-2020 12:22:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971903
Page 129 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
7Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
7Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ebe\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-2021-5683-0971904
Page 130 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
8Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
8Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
8Nov-17-2020 12:21:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971905
Page 131 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Nov-25-2020 08:17:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
9Nov-24-2020 12:35:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
9Nov-24-2020 12:34:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
9Nov-19-2020 16:44:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0971906
Page 132 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-19-2020 16:37:46 (UTC-05:00) Eastern Time
(US & Canada)sample was collected.
3Nov-19-2020 16:37:25 (UTC-05:00) Eastern Time
(US & Canada)sample was collected.
3Nov-18-2020 09:41:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ebe\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-2021-5683-0971907
Page 133 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971908
Page 134 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971909
Page 135 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971910
Page 136 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971911
Page 137 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971912
Page 138 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971913
Page 139 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-24-2020 15:12:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971914
Page 140 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-25-2020 08:28:27 (UTC-05:00) Eastern Time
(US & Canada)
FormNov-24-2020 15:12:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971915
Page 141 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-25-2020 08:28:27 (UTC-05:00) Eastern Time
(US & Canada)
1Nov-24-2020 15:12:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971916
Page 142 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-25-2020 08:28:27 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-24-2020 15:12:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971917
Page 143 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-25-2020 08:28:27 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-24-2020 15:12:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971918
Page 144 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:13:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971919
Page 145 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:13:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971920
Page 146 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:13:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971921
Page 147 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:13:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971922
Page 148 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:13:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971923
Page 149 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971924
Page 150 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971925
Page 151 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971926
Page 152 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971927
Page 153 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971928
Page 154 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971929
Page 155 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971930
Page 156 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971931
Page 157 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971932
Page 158 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971933
Page 159 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971934
Page 160 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971935
Page 161 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971936
Page 162 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971937
Page 163 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971938
Page 164 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971939
Page 165 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971940
Page 166 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971941
Page 167 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971942
Page 168 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971943
Page 169 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971944
Page 170 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971945
Page 171 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971946
Page 172 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971947
Page 173 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971948
Page 174 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971949
Page 175 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971950
Page 176 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971951
Page 177 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971952
Page 178 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971953
Page 179 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971954
Page 180 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971955
Page 181 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:14:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971956
Page 182 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971957
Page 183 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971958
Page 184 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971959
Page 185 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971960
Page 186 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971961
Page 187 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971962
Page 188 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971963
Page 189 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971964
Page 190 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971965
Page 191 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971966
Page 192 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971967
Page 193 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971968
Page 194 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971969
Page 195 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971970
Page 196 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971971
Page 197 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971972
Page 198 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971973
Page 199 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971974
Page 200 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971975
Page 201 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971976
Page 202 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971977
Page 203 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971978
Page 204 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971979
Page 205 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971980
Page 206 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971981
Page 207 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971982
Page 208 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971983
Page 209 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971984
Page 210 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971985
Page 211 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971986
Page 212 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971987
Page 213 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971988
Page 214 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971989
Page 215 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971990
Page 216 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971991
Page 217 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971992
Page 218 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 hNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971993
Page 219 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971994
Page 220 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971995
Page 221 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971996
Page 222 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971997
Page 223 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971998
Page 224 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971999
Page 225 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972000
Page 226 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-24-2020 15:15:07 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972001
Page 227 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972002
Page 228 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972003
Page 229 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972004
Page 230 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972005
Page 231 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972006
Page 232 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-24-2020 15:15:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972007
Page 233 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:16:00 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972008
Page 234 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:16:00 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972009
Page 235 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-24-2020 15:16:00 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972010
Page 236 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:16:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972011
Page 237 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:16:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972012
Page 238 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:16:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972013
Page 239 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:16:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972014
Page 240 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972015
Page 241 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972016
Page 242 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972017
Page 243 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972018
Page 244 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972019
Page 245 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972020
Page 246 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-24-2020 15:16:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972021
Page 247 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:17:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972022
Page 248 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:17:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972023
Page 249 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:17:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972024
Page 250 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:17:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972025
Page 251 of 406
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:17:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972026
Page 252 of 406
***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: 10971061 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 Feb-24-2021 19:06:19 (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-22-2021 12:33:17 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom Christensen Approved Jan-27-2021 21:01:37 (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 Jan-26-2021 14:16:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom Christensen Approved Jan-25-2021 19:38:57 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972027
Page 253 of 406
***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: 10971061 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 Jan-25-2021 14:56:00 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom Christensen Approved Jan-20-2021 20:48:21 (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 09:20:15 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom Christensen Approved Nov-17-2020 16:38:06 (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-17-2020 12:02:32 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972028
Page 254 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
N/A
Tom Christensen Approved Nov-16-2020 17:21:07 (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 13:33:45 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom Christensen Approved Nov-13-2020 18:17:06 (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.
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972029
Page 255 of 406
***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: 10971061 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-28-2020 13:57:22
(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-28-2020 13:57:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972030
Page 256 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 13:57:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972031
Page 257 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 13:57:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10971061Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 13:57:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 13:58:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 13:58:03
(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-28-2020 13:58:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ebe\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-2021-5683-0972032
Page 258 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 08:50:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-02-2020 08:24:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Randomization
number and date have
been entered correctly
Sep-01-2020 02:04:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS Reconciliation:
Randomization date
and randomization
number recorded at
Impala but not
recorded at Inform.
Please review and
update data as
appropriate. Else,
clarify. Thank you.
Aug-28-2020 15:56:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3ebe\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)
FDA-CBER-2021-5683-0972033
Page 259 of 406
***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: 10971061 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-28-2020 15:57:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 15:57:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 15:57:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972034
Page 260 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 15:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Peripheral Vascular
Disease
Start Date: Feb/18/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:16:36
(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
Nov-09-2020 16:04:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 2: Closed Response satisfies
query
Nov-09-2020 09:59:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered pulmonary Fibrosis
added to medical
history.
Nov-07-2020 08:15:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 2: Opened As confirmed in the
AE log, subject has a
known medial
condition of apical
fibrosis. Please
update MedHx
accordingly.
Nov-06-2020 16:23:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-06-2020 10:39:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Added in history
Nov-06-2020 02:46:45
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Opened Clinical On review of
SAE report for kidney
090177e196ae3ebe\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) (4)
(b) (4)
FDA-CBER-2021-5683-0972035
Page 261 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US & Canada) injury, Medical Hx of
HTN was mentioned,
yet it does not appear
in the CRF. Please
review for clinical
relevance to this
safety event and
update Med Hx log
CRF if appropriate.
Nov-05-2020 10:58:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidate Clinical On review of
SAE report for kidney
injury, Medical Hx of
HTN was mentioned,
yet it does not appear
in the CRF. Please
review for clinical
relevance to this
safety event and
update Med Hx log
CRF if appropriate.
Sep-03-2020 15:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral Vascular DiseaseInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 15:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 15:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-03-2020 15:17:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Chronic depressi
on
Start Date: Apr/22/2018
Ongoing: YESInitial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972036
Page 262 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:17:32
(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
Nov-12-2020 07:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Nov-11-2020 15:29:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject meets
qualification .
Nov-10-2020 14:02:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD CLIN: The
subject presents at
screening with
ongoing depression.
Please confirm subject
meets eligibility per
exclusion criteria 1;
else, document
deviation on I/E CRF
and report deviation
as applicable.
Sep-03-2020 15:17:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic depressionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 15:17:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/22/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 15:17:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3ebe\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) (4)
(b) (4)
FDA-CBER-2021-5683-0972037
Page 263 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-03-2020 15:18:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History Term
:COPD
Start Date: Mar/23/201
8
Ongoing: YESInitial Entry
Sep-03-2020 15:17:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:COPD
Start Date: Mar/23/201
8
Ongoing:Initial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972038
Page 264 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:17:59
(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
Nov-06-2020 16:23:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-06-2020 11:09:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered This was found on CT
of the chest performed
22Oct2020. This was
unknown prior to that
time so it should not
be added as history.
Nov-06-2020 04:07:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical On review of
SAE report for kidney
injury, Med Hx of
pulmonary fibrosis
was reported (with no
start date). If this is a
pre-existing condition,
please add to Med Hx
and submit start date
to SAE.
Nov-05-2020 11:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Candidate Clinical On review of
SAE report for kidney
injury, Med Hx of
pulmonary fibrosis
was reported (with no
start date). If this is a
pre-existing condition,
please add to Med Hx
and submit start date
to SAE.
Sep-06-2020 08:09:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Sep-05-2020 14:50:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered The participant is not
currently receiving or
plans to receive
systemic
090177e196ae3ebe\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) (4)
FDA-CBER-2021-5683-0972039
Page 265 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
corticosteroids with
the exception of
Inhaled Steroids due
to this condition.
Sep-04-2020 15:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: The subject
presents at screening
with ongoing COPD.
Please confirm that
participant is or is not
currently
receiving/plans to
receive systemic
corticosteroids with
the exception of
Inhaled Steroids due
to this condition.
Sep-03-2020 15:17:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COPDInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 15:17:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/23/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 15:18:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-03-2020 15:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: Fibromyalgia
Start Date: Mar/23/2018
Ongoing: YESInitial Entry
090177e196ae3ebe\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972040
Page 266 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:18:47
(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
Sep-03-2020 15:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FibromyalgiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 15:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/23/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 15:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 15:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Degenerative Lumb
ar disc
Start Date: Mar/23/2018
Ongoing: YESInitial Entry
090177e196ae3ebe\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-2021-5683-0972041
Page 267 of 406
***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: 10971061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/S
…[truncated]