Document text
Page 1 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916509
Page 2 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916510
Page 3 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10571052]
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): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916511
Page 4 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916512
Page 5 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916513
Page 6 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916514
Page 7 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE II DIABETES]
Start Date: Mar/18/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: Aug/19/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: Aug/19/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: Mar/18/1993
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: Aug/19/2018
Ongoing: YES
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916515
Page 8 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS]
Start Date: Mar/18/2003
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC PAIN]
Start Date: Mar/18/2003
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY BYPASS GRAFT]
Start Date: Aug/19/2018
Ongoing: NO
End Date:
Aug/19/2018
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBESITY]
Start Date: UNK/UNK/2000
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST MENOPAUSAL]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916516
Page 9 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL LEG EDEMA]
Start Date: UNK/UNK/2019
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOCARDIAL INFARCTION]
Start Date: Aug/19/2018
Ongoing: NO
End Date:
Aug/19/2018
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT HEMITHYROIDECTOMY]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION ]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916517
Page 10 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [92.2]
3.Unit: kg
4.Height: [164.5]
5.Unit: cm
6.Body Mass Index: [34.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916518
Page 11 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916519
Page 12 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [233181]
3.Randomization Group: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916520
Page 13 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BP1GSK]
5.bSample ID [BP1GSL]
5.cSample ID [BP1GSM]
5.dSample ID [BPJ0KP]
5.eSample ID [BPJ0KR]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916521
Page 14 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BP1G9B]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916522
Page 15 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/19/2020 12:25
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916523
Page 16 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916524
Page 17 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916525
Page 18 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916526
Page 19 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916527
Page 20 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP1GH0]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916528
Page 21 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/9/2020 15:08
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916529
Page 22 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020 Comments
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916530
Page 23 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0K0C]
5.bSample ID [BR0K0D]
5.cSample ID [BR0K0F]
5.dSample ID [BS6GKB]
5.eSample ID [BS6GKC]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916531
Page 24 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916532
Page 25 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916533
Page 26 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916534
Page 27 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916535
Page 28 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916536
Page 29 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916537
Page 30 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916538
Page 31 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/8/2020
2.Date of First Symptom Started: Sep/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
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
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916539
Page 32 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.Symptoms - Other Text: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916540
Page 33 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/5/2020
SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Sep/23/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916541
Page 34 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/5/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: Unknown Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916542
Page 35 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/23/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA certified lab SARS-CoV-2 by PCR]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916543
Page 36 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[patient hospitalized] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916544
Page 37 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[patient hospitalized]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916545
Page 38 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [HOSPITALIZATION]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916546
Page 39 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Sep/23/2020 NO
Discharge Date:
Sep/29/2020
Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916547
Page 40 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/23/2020
4.Ongoing? NO
Discharge Date:
Sep/29/2020
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916548
Page 41 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES HIGH FLOW OXYGEN
THERAPY HIGH FLOW OXYGEN
THERAPY Oct/1/2
020 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916549
Page 42 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1] Comments
2.Concomitant Non-drug Treatment
Pre-specified:YES Comments
3.Treatment: HIGH FLOW OXYGEN THERAPY Comments
4.Treatment: [HIGH FLOW OXYGEN THERAPY] Comments
5.Start Date: Oct/1/2020 Comments
6.Ongoing? YES Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916550
Page 43 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[PNEUMONIA]
Date of Diagnosis:
Oct/6/2020
3.Toxicity Grade: 3
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916551
Page 44 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916552
Page 45 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916553
Page 46 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916554
Page 47 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
2.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/23/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 15
28 Aspartate Amin
otransferase_PX
28 40
35 Alkaline Phosph
atase_PX35 104
21 Bilirubin_PX21 0.4
47 Blood Urea Nitr
ogen_PX47 9
48 Creatinine_PX4
8 0.9 Repeating
Pages
3.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/24/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 6
48 Creatinine_PX4
8 0.8 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916555
Page 48 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
4.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/26/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 5
48 Creatinine_PX4
8 0.9 Repeating
Pages
5.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/27/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 8
48 Creatinine_PX4
8 1.0 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916556
Page 49 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
6.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/28/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 16
48 Creatinine_PX4
8 1.3 Repeating
Pages
7.CLINICAL
CHEMISTR
Y St. Vincents Hospital Riverside
1 Shircliff Way Jacksonville FL
32204 Sep/29/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 19
48 Creatinine_PX4
8 1.4 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916557
Page 50 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916558
Page 51 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916559
Page 52 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916560
Page 53 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916561
Page 54 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [15]
Not Done:
LNMT Low
[17]
High
[63]
Unit
U/L
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916562
Page 55 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [40]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [104]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.3]
High
[1.8]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916563
Page 56 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [9]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.9]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916564
Page 57 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916565
Page 58 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916566
Page 59 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [6]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.8]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916567
Page 60 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916568
Page 61 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916569
Page 62 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [5]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.9]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916570
Page 63 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916571
Page 64 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916572
Page 65 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [8]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.0]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916573
Page 66 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/28/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916574
Page 67 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916575
Page 68 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [16]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.3]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916576
Page 69 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/29/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916577
Page 70 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916578
Page 71 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.4]
Not Done:
LNMT Low
[0.6]
High
[1.2]
Unit
mg/dL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916579
Page 72 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916580
Page 73 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
2.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/23/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.2
2 Hematocrit
_PX2 27
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 265
7 Leukocytes
_PX7 [ ]
608 Neutrophil
s_PX608 8.70
609 Eosinophil
s_PX609 0.20
612 Monocytes
_PX612 0.60
610 Basophils_
PX610 0.10
611 Lymphocyt
es_PX611 1.50
Repeating
Pages
3.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/24/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.6
2 Hematocrit
_PX2 28.4
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 250
7 Leukocytes
_PX7 [ ] Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916581
Page 74 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
Sponsor-Defi
ned Identifie
rTest:Res
ult:
608 Neutrophil
s_PX608 77
609 Eosinophil
s_PX609 2
612 Monocytes
_PX612 6
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 15
4.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/26/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.2
2 Hematocrit
_PX2 27.6
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 231
7 Leukocytes
_PX7 [ ]
608 Neutrophil
s_PX608 71
609 Eosinophil
s_PX609 2
612 Monocytes
_PX612 8
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 18 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916582
Page 75 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
5.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/27/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.1
2 Hematocrit
_PX2 26.8
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 201
7 Leukocytes
_PX7 [ ]
608 Neutrophil
s_PX608 73
609 Eosinophil
s_PX609 2
612 Monocytes
_PX612 9
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 15 Repeating
Pages
6.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/28/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.0
2 Hematocrit
_PX2 26.6
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 197
7 Leukocytes
_PX7 [ ] Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916583
Page 76 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
Sponsor-Defi
ned Identifie
rTest:Res
ult:
608 Neutrophil
s_PX608 72
609 Eosinophil
s_PX609 3
612 Monocytes
_PX612 10
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 14
7.HEMATOL
OGY St. Vincents Hospital Riverside 1 S
hircliff Way Jacksonville FL 32204
Sep/29/2
020 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 8.7
2 Hematocrit
_PX2 28.4
3 Erythrocyt
es_PX3 [ ]
5 Platelets_P
X5 217
7 Leukocytes
_PX7 [ ]
608 Neutrophil
s_PX608 72
609 Eosinophil
s_PX609 3
612 Monocytes
_PX612 10
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 14 Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916584
Page 77 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916585
Page 78 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916586
Page 79 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916587
Page 80 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916588
Page 81 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916589
Page 82 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916590
Page 83 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.2]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [27]
Not Done:
LNMT Low
[36.0]
High
[46.0]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916591
Page 84 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [265]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916592
Page 85 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [8.70]
Not Done:
LNMT Low
[36]
High
[70]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.20]
Not Done:
LNMT Low
[0]
High
[7]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.60]
Not Done:
LNMT Low
[0]
High
[10]
Unit
/uL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916593
Page 86 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.10]
Not Done:
LNMT Low
[0]
High
[2]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.50]
Not Done:
LNMT Low
[25]
High
[45]
Unit
/uL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916594
Page 87 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.6]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/L
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [28.4]
Not Done:
LNMT Low
[36.0]
High
[46.0]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916595
Page 88 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [250]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916596
Page 89 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [77]
Not Done:
LNMT Low
[36]
High
[70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [2]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [6]
Not Done:
LNMT Low
[0]
High
[10]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916597
Page 90 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [15]
Not Done:
LNMT Low
[25]
High
[45]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916598
Page 91 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.2]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [27.6]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916599
Page 92 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [231]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916600
Page 93 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [71]
Not Done:
LNMT Low
[36]
High
[70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [2]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [8]
Not Done:
LNMT Low
[0]
High
[10]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916601
Page 94 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [18]
Not Done:
LNMT Low
[25]
High
[45]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916602
Page 95 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.1]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [26.8]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916603
Page 96 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [201]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916604
Page 97 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [73]
Not Done:
LNMT Low
[36]
High
[70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [2]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [9]
Not Done:
LNMT Low
[0]
High
[10]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916605
Page 98 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [15]
Not Done:
LNMT Low
[25]
High
[45]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916606
Page 99 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/28/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.0]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [26.6]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916607
Page 100 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [197]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916608
Page 101 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [72]
Not Done:
LNMT Low
[36]
High
[70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [3]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [10]
Not Done:
LNMT Low
[0]
High
[10]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916609
Page 102 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [14]
Not Done:
LNMT Low
[25]
High
[45]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916610
Page 103 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Vincents Hospital Riverside 1 Shircliff Way Jacksonville FL 32204]
3.Collection Date: Sep/29/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.7]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [28.4]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916611
Page 104 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [217]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916612
Page 105 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [72]
Not Done:
LNMT Low
[36]
High
[70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [3]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [10]
Not Done:
LNMT Low
[0]
High
[10]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916613
Page 106 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [14]
Not Done:
LNMT Low
[25]
High
[45]
Unit
%
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916614
Page 107 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1. DELETED Not Done Record Identifier: Systolic: Diastolic:
Not Done Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916615
Page 108 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
2. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 172 98 Repeating Pages
3. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 178 98 Repeating Pages
4. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 145 89 Repeating Pages
5. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 133 62 Repeating Pages
6. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 133 62 Repeating Pages
7. DELETED Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 133 62 Repeating Pages
8. Sep/28/2020 Record Identifier: Systolic: Diastolic:
1 99 54 Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916616
Page 109 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
9.Sep/23/2020 Record Identifier: Systolic: Diastolic:
1 133 62 Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916617
Page 110 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Incomplete, Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [ ] Comments
Diastolic: [ ] Comments
Respiratory Rate in
respirations/minute:[ ] Comments
Heart Rate in beats/minute: [ ] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916618
Page 111 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [172] Comments
Diastolic: [98] Comments
Respiratory Rate in
respirations/minute:[20] Comments
Heart Rate in beats/minute: [99] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916619
Page 112 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [178] Comments
Diastolic: [98] Comments
Respiratory Rate in
respirations/minute:[20] Comments
Heart Rate in beats/minute: [119] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916620
Page 113 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [145] Comments
Diastolic: [89] Comments
Respiratory Rate in
respirations/minute:[20] Comments
Heart Rate in beats/minute: [110] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916621
Page 114 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [133] Comments
Diastolic: [62] Comments
Respiratory Rate in
respirations/minute:[16] Comments
Heart Rate in beats/minute: [88] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916622
Page 115 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [133] Comments
Diastolic: [62] Comments
Respiratory Rate in
respirations/minute:[16] Comments
Heart Rate in beats/minute: [88] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916623
Page 116 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [133] Comments
Diastolic: [62] Comments
Respiratory Rate in
respirations/minute:[16] Comments
Heart Rate in beats/minute: [88] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916624
Page 117 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [99]
Diastolic: [54]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [78]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916625
Page 118 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [133]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [119]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916626
Page 119 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1. DELETED Record Identifier: Oxygen Saturation
Not Done Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916627
Page 120 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
2. Sep/23/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
3. DELETED Sep/23/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
4. DELETED Sep/23/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
5. DELETED Sep/23/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
6. DELETED Sep/23/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
7. DELETED Sep/23/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
8. Sep/28/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916628
Page 121 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Incomplete, Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: // Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [ ] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916629
Page 122 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916630
Page 123 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916631
Page 124 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916632
Page 125 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916633
Page 126 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916634
Page 127 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916635
Page 128 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916636
Page 129 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916637
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916638
Page 131 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916639
Page 132 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916640
Page 133 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of
Assessm
entLocation of
AssessmentImaging
MethodOverall AssessmentForm Insta
nce
1.Not Don
e Not Done Not Done Not Done Repeating
Pages
2.Sep/23/2
020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Impression: bilateral mid to lower lung airspace opacities differential
includes atelectasis versus pneumonia.
Repeating
Pages
3.Sep/23/2
020 CHEST OTHER
If other, s
pecify:
EKG
ABNORMAL
If abnormal, specify findings:
Sinus tachycardia, incomplete right bundle branch block, probably le
ft atrial enlargement, inferior infarct, old.
Repeating
Pages
4.Sep/24/2
020 CHEST OTHER
If other, s
pecify:
ECHO
NORMAL Repeating
Pages
5.Sep/24/2
020 OTHER
If other, sp
ecify:
Gastroint
estinal
OTHER
If other, s
pecify:
EGD
NORMAL Repeating
Pages
6.Sep/28/2
020 CHEST OTHER
If other, s
pecify:
Stress
EKG
NORMAL Repeating
Pages
7.Sep/26/2
020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Impression: Stable bilateral airspace opacities. Small bilateral pleura
l effusions. No pneumothorax.
Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916641
Page 134 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of
Assessm
entLocation of
AssessmentImaging
MethodOverall AssessmentForm Insta
nce
8.Sep/23/2
020 CHEST OTHER
If other, s
pecify:
CT An
giograp
hy
ABNORMAL
If abnormal, specify findings:
Impression: Bilateral patchy and linear opacities. This is limited in e
valuation but differential includes scar, atelectatisis versus infectious
/inflammatory process or edema.
Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916642
Page 135 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916643
Page 136 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/23/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Impression: bilateral mid to lower lung airspace opacities differential includes
atelectasis versus pneumonia.]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916644
Page 137 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/23/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: OTHER
If other, specify:
[EKG]
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Sinus tachycardia, incomplete right bundle branch block, probably left atrial
enlargement, inferior infarct, old.]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916645
Page 138 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/24/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: OTHER
If other, specify:
[ECHO]
4.Assessment: NORMAL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916646
Page 139 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/24/2020
2.Location of Assessment: OTHER
If other, specify:
[Gastrointestinal]
3.Type of Imaging Exam: OTHER
If other, specify:
[EGD]
4.Assessment: NORMAL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916647
Page 140 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/28/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: OTHER
If other, specify:
[Stress EKG]
4.Assessment: NORMAL
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916648
Page 141 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/26/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Impression: Stable bilateral airspace opacities. Small bilateral pleural effusions.
No pneumothorax.]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916649
Page 142 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/23/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: OTHER
If other, specify:
[CT Angiography]
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Impression: Bilateral patchy and linear opacities. This is limited in evaluation but
differential includes scar, atelectatisis versus infectious/inflammatory process or
edema.]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916650
Page 143 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - 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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916651
Page 144 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Typ
eForm Instance
1. Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916652
Page 145 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916653
Page 146 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916654
Page 147 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916655
Page 148 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916656
Page 149 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916657
Page 150 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916658
Page 151 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916659
Page 152 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916660
Page 153 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916661
Page 154 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916662
Page 155 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916663
Page 156 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916664
Page 157 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916665
Page 158 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916666
Page 159 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916667
Page 160 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916668
Page 161 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916669
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916670
Page 163 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916671
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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_A1
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916672
Page 165 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [BR0KT2]
5.bSample ID [BR0KT3]
5.cSample ID [BR0KT4]
5.dSample ID [BLBSSK]
5.eSample ID [BLBSSL]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916673
Page 166 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916674
Page 167 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916675
Page 168 of 796
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916676
Page 169 of 796
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916677
Page 170 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916678
Page 171 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916679
Page 172 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 PNEUMONI
A Sep/20/2020 UNK:U
NK NO
End Date Time:
Oct/4/2020 08:00
Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916680
Page 173 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[PNEUMONIA]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 08:00
6.Toxicity Grade: 2
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:
[COMMUNITY ACQUIRED PNEUMONIA]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916681
Page 174 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020385783]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916682
Page 175 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916683
Page 176 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916684
Page 177 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916685
Page 178 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916686
Page 179 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916687
Page 180 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916688
Page 181 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916689
Page 182 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916690
Page 183 of 796
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916691
Page 184 of 796
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916692
Page 185 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916693
Page 186 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916694
Page 187 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916695
Page 188 of 796
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916696
Page 189 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916697
Page 190 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916698
Page 191 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916699
Page 192 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916700
Page 193 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916701
Page 194 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916702
Page 195 of 796
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916703
Page 196 of 796
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916704
Page 197 of 796
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021 Comments
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION Comments
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916705
Page 198 of 796
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916706
Page 199 of 796
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916707
Page 200 of 796
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916708
Page 201 of 796
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916709
Page 202 of 796
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916710
Page 203 of 796
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916711
Page 204 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916712
Page 205 of 796
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916713
Page 206 of 796
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0916714
Page 207 of 796
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-19-2020 17:19:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916715
Page 208 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916716
Page 209 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Aug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916717
Page 210 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Aug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916718
Page 211 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Aug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916719
Page 212 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Aug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916720
Page 213 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Aug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916721
Page 214 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916722
Page 215 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916723
Page 216 of 796
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-19-2020 17:24:02 (UTC-05:00) Eastern Time
(US & Canada)NOT WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916724
Page 217 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916725
Page 218 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916726
Page 219 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916727
Page 220 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916728
Page 221 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916729
Page 222 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916730
Page 223 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916731
Page 224 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916732
Page 225 of 796
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-10-2020 12:43:18 (UTC-05:00) Eastern Time
(US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916733
Page 226 of 796
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-21-2020 16:35:26 (UTC-05:00) Eastern Time
(US & Canada)Due to delay criteria/SAE visit 3 was out of
window
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916734
Page 227 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916735
Page 228 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916736
Page 229 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916737
Page 230 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916738
Page 231 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916739
Page 232 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
5Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916740
Page 233 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Oct-14-2020 17:19:08 (UTC-05:00) Eastern Time
(US & Canada)Unknown
6Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
6Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916741
Page 234 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
7Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
7Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916742
Page 235 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
8Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
8Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916743
Page 236 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
9Oct-14-2020 17:17:06 (UTC-05:00) Eastern Time
(US & Canada)
9Oct-13-2020 13:23:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916744
Page 237 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormNov-04-2020 09:48:31 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-13-2020 13:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916745
Page 238 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Nov-04-2020 09:48:31 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-13-2020 13:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916746
Page 239 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Nov-04-2020 09:48:31 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-13-2020 13:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916747
Page 240 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Nov-04-2020 09:48:31 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-13-2020 13:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916748
Page 241 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Nov-04-2020 09:48:31 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-13-2020 13:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916749
Page 242 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916750
Page 243 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916751
Page 244 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916752
Page 245 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916753
Page 246 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916754
Page 247 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
5Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916755
Page 248 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Oct-08-2020 17:26:21 (UTC-05:00) Eastern Time
(US & Canada)
6Oct-08-2020 17:26:08 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916756
Page 249 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-13-2020 13:24:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916757
Page 250 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-13-2020 13:24:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916758
Page 251 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-13-2020 13:24:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916759
Page 252 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-13-2020 13:24:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916760
Page 253 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-13-2020 13:24:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916761
Page 254 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0916762
Page 255 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916763
Page 256 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916764
Page 257 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916765
Page 258 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916766
Page 259 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916767
Page 260 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916768
Page 261 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916769
Page 262 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916770
Page 263 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916771
Page 264 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916772
Page 265 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916773
Page 266 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916774
Page 267 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916775
Page 268 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916776
Page 269 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916777
Page 270 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916778
Page 271 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916779
Page 272 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916780
Page 273 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916781
Page 274 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916782
Page 275 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916783
Page 276 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916784
Page 277 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916785
Page 278 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916786
Page 279 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.fOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916787
Page 280 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.fOct-13-2020 13:27:51 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e20\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0916788
Page 281 of 796
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571052 Subject Initials: ---
Generated By: Generated Time (GMT)
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