Document text
Page 1 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917831
Page 2 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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
Oct/16/2020
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917832
Page 3 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10571327]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917833
Page 4 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917834
Page 5 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917835
Page 6 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917836
Page 7 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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 Mellitus]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Obstructive Pulmonary Disease]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2002
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholelithiasis]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917837
Page 8 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystectomy]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cesarean Section]
Start Date: Sep/23/2002
Ongoing: NO
End Date:
Sep/23/2002
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cesarean Section]
Start Date: Jul/27/1999
Ongoing: NO
End Date:
Jul/27/1999
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Wrist Carpal Tunnel Surgery]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917838
Page 9 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Wrist Carpal Tunnel Surgery]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/2020
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Hands Carpal Tunnel Syndrome]
Start Date: UNK/UNK/2019
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myocardial Infarction]
Start Date: May/28/2017
Ongoing: NO
End Date:
May/28/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Stent Placement]
Start Date: May/28/2017
Ongoing: NO
End Date:
May/28/2017
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917839
Page 10 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1990
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1970
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: UNK/UNK/2017
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2011
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917840
Page 11 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/2016
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917841
Page 12 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917842
Page 13 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [88.6]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [36.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917843
Page 14 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917844
Page 15 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [269204]
3.Randomization Group: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917845
Page 16 of 426
***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, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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/16/2020
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 [BR0JVS]
5.bSample ID [BR0JVT]
5.cSample ID [BR0JVV]
5.dSample ID [BS6GG8]
5.eSample ID [BS6GG9]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917846
Page 17 of 426
***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, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Oct/16/2020
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 [BR095S]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917847
Page 18 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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: Oct/16/2020 11:17
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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917848
Page 19 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917849
Page 20 of 426
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917850
Page 21 of 426
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917851
Page 22 of 426
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917852
Page 23 of 426
***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, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Nov/4/2020
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 [BR0990]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917853
Page 24 of 426
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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: Nov/4/2020 14:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917854
Page 25 of 426
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917855
Page 26 of 426
***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, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Dec/2/2020
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 [BR0L2S]
5.bSample ID [BR0L2T]
5.cSample ID [BR0L2V]
5.dSample ID [BLBSZB]
5.eSample ID [BLBSZC]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917856
Page 27 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917857
Page 28 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/20/2020
2.Date of First Symptom Started: Oct/17/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/2/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917858
Page 29 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917859
Page 30 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917860
Page 31 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917861
Page 32 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [CV59672]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917862
Page 33 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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:[TELEHEALTH VISIT]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917863
Page 34 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [HOSPITAL]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917864
Page 35 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917865
Page 36 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917866
Page 37 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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?NO
3.Toxicity Grade: 2
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917867
Page 38 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917868
Page 39 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917869
Page 40 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY QUEST DIAGNOSTICS 4225 E
Fowler Ave, Tampa, FL 33617 Nov/18/2
020 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
329 Not
Done
30 Not
Done
28 Not
Done
35 Not
Done
54
21 Not
Done
0.4
47 Not
Done
19
48 Not
Done
1.10
Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917870
Page 41 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [QUEST DIAGNOSTICS 4225 E Fowler Ave, Tampa, FL 33617] Comments
3.Collection Date: Nov/18/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917871
Page 42 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [54] Comments
Not Done: Comments
LNMT Low
[37]
High
[153]
Unit
U/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [0.4] Comments
Not Done: Comments
LNMT Low
[0.2]
High
[1.2]
Unit
mg/dLComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917872
Page 43 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [19] Comments
Not Done: Comments
LNMT Low
[7]
High
[25]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [1.10] Comments
Not Done: Comments
LNMT Low
[0.50]
High
[1.05]
Unit
mg/dLComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917873
Page 44 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY QUEST DIAGNOSTICS 4225 E
Fowler Ave, Tampa, FL 33617 Nov/18/2
020 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Not
Done 12.7
2 Not
Done 39.3
3 Not
Done
5 Not
Done 215
7 Not
Done
608 Not
Done 938
7
609 Not
Done 211
612 Not
Done 670
610 Not
Done 124
611 Not
Done 200
9 Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917874
Page 45 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY Comments
2.Laboratory Name and Address [QUEST DIAGNOSTICS 4225 E Fowler Ave, Tampa, FL 33617] Comments
3.Collection Date: Nov/18/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [12.7] Comments
Not Done: Comments
LNMT Low
[11.7]
High
[15.5]
Unit
g/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [39.3] Comments
Not Done: Comments
LNMT Low
[35.0]
High
[45.0]
Unit
%Comments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917875
Page 46 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [215] Comments
Not Done: Comments
LNMT Low
[140]
High
[400]
Unit
/uLComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917876
Page 47 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [9387] Comments
Not Done: Comments
LNMT Low
[1500]
High
[7800]
Unit
/uLComments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [211] Comments
Not Done: Comments
LNMT Low
[15]
High
[500]
Unit
/uLComments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [670] Comments
Not Done: Comments
LNMT Low
[200]
High
[950]
Unit
/uLComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917877
Page 48 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [124] Comments
Not Done: Comments
LNMT Low
[0]
High
[200]
Unit
/uLComments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [2009] Comments
Not Done: Comments
LNMT Low
[850]
High
[3900]
Unit
/uLComments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917878
Page 49 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917879
Page 50 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917880
Page 51 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917881
Page 52 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917882
Page 53 of 426
***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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917883
Page 54 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917884
Page 55 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917885
Page 56 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917886
Page 57 of 426
***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: 10571327 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.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917887
Page 58 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917888
Page 59 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/18/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917889
Page 60 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/18/2020Form: 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: 10571327 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/18/2020
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 [BR0KVZ]
5.bSample ID [BR0KW0]
5.cSample ID [BR0KW1]
5.dSample ID [BLBSTV]
5.eSample ID [BLBSTW]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917890
Page 61 of 426
***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: 10571327 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:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917891
Page 62 of 426
***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: 10571327 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 [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917892
Page 63 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 LEFT PERITONSILLAR
ABSCESS Oct/22/2020 UN
K:UNK NO
End Date Time:
Nov/23/2020 UNK:UN
K
Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917893
Page 64 of 426
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10571327 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)[LEFT PERITONSILLAR ABSCESS]
4.Start Date Time: Oct/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/23/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917894
Page 65 of 426
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown, medical records did not identify causation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020412908]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917895
Page 66 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917896
Page 67 of 426
***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: 10571327 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[ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917897
Page 68 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917898
Page 69 of 426
***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: 10571327 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: //
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917899
Page 70 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917900
Page 71 of 426
***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: 10571327 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?
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917901
Page 72 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917902
Page 73 of 426
***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: 10571327 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?
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917903
Page 74 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917904
Page 75 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917905
Page 76 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917906
Page 77 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917907
Page 78 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917908
Page 79 of 426
***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: 10571327 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:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917909
Page 80 of 426
***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: 10571327 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:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917910
Page 81 of 426
***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: 10571327 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?
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917911
Page 82 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917912
Page 83 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917913
Page 84 of 426
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917914
Page 85 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917915
Page 86 of 426
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 1/2
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917916
Page 87 of 426
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917917
Page 88 of 426
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917918
Page 89 of 426
***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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917919
Page 90 of 426
***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: 10571327 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: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917920
Page 91 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917921
Page 92 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917922
Page 93 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917923
Page 94 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917924
Page 95 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/26/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917925
Page 96 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Jan/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBB5S]
5.bSample ID [BRBB5T]
5.cSample ID [BRBB5V]
5.dSample ID [BS3DS7]
5.eSample ID [BS3DS8]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917926
Page 97 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Jan/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMYH1]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917927
Page 98 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917928
Page 99 of 426
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917929
Page 100 of 426
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/15/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917930
Page 101 of 426
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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:
Feb/15/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMYLV]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917931
Page 102 of 426
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/15/2021 10:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917932
Page 103 of 426
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917933
Page 104 of 426
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917934
Page 105 of 426
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917935
Page 106 of 426
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917936
Page 107 of 426
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917937
Page 108 of 426
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917938
Page 109 of 426
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917939
Page 110 of 426
***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: 10571327 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 Dec/2/2020
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917940
Page 111 of 426
***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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917941
Page 112 of 426
***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: 10571327 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
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917942
Page 113 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-19-2020 08:48:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917943
Page 114 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917944
Page 115 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917945
Page 116 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917946
Page 117 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917947
Page 118 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917948
Page 119 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917949
Page 120 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
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FDA-CBER-2021-5683-0917950
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0917951
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
8Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
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FDA-CBER-2021-5683-0917952
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Header Text: c4591001
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
9Oct-20-2020 17:13:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
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FDA-CBER-2021-5683-0917953
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
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FDA-CBER-2021-5683-0917954
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
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FDA-CBER-2021-5683-0917955
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0917956
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917957
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917958
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917959
Page 130 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Oct-20-2020 17:12:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917960
Page 131 of 426
***Confidential***
Header Text: c4591001
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:12:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917961
Page 132 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:12:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0917962
Page 133 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:12:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917963
Page 134 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:12:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917964
Page 135 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-20-2020 17:12:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917965
Page 136 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917966
Page 137 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Nov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917967
Page 138 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Nov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
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FDA-CBER-2021-5683-0917968
Page 139 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Nov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917969
Page 140 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Nov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917970
Page 141 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917971
Page 142 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917972
Page 143 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
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FDA-CBER-2021-5683-0917973
Page 144 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
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FDA-CBER-2021-5683-0917974
Page 145 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917975
Page 146 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917976
Page 147 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917977
Page 148 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917978
Page 149 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0917979
Page 150 of 426
***Confidential***
Header Text: c4591001
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on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917980
Page 151 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917981
Page 152 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917982
Page 153 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917983
Page 154 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917984
Page 155 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917985
Page 156 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917986
Page 157 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917987
Page 158 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917988
Page 159 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917989
Page 160 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917990
Page 161 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917991
Page 162 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917992
Page 163 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917993
Page 164 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917994
Page 165 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917995
Page 166 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917996
Page 167 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917997
Page 168 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 15:21:41 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917998
Page 169 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917999
Page 170 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Nov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918000
Page 171 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Nov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918001
Page 172 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Nov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918002
Page 173 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Nov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918003
Page 174 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918004
Page 175 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918005
Page 176 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918006
Page 177 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.aOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918007
Page 178 of 426
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918008
Page 179 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918009
Page 180 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918010
Page 181 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.bOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918011
Page 182 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918012
Page 183 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918013
Page 184 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918014
Page 185 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.cOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918015
Page 186 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918016
Page 187 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918017
Page 188 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918018
Page 189 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.dOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918019
Page 190 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918020
Page 191 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918021
Page 192 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918022
Page 193 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.eOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918023
Page 194 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918024
Page 195 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918025
Page 196 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918026
Page 197 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 fOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918027
Page 198 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918028
Page 199 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918029
Page 200 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918030
Page 201 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.gOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918031
Page 202 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 hOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918032
Page 203 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 hOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918033
Page 204 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 hOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918034
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5 hOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918035
Page 206 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.iOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918036
Page 207 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.iOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918037
Page 208 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.iOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918038
Page 209 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.iOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918039
Page 210 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.jOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918040
Page 211 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.jOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918041
Page 212 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.jOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918042
Page 213 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jNov-24-2020 14:36:28 (UTC-05:00) Eastern
Time (US & Canada)
5.jOct-20-2020 17:14:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918043
Page 214 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918044
Page 215 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918045
Page 216 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aOct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918046
Page 217 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aOct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918047
Page 218 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aOct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918048
Page 219 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aOct-20-2020 17:15:14 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918049
Page 220 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:14:18 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918050
Page 221 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:14:18 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918051
Page 222 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aOct-20-2020 17:14:18 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
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FDA-CBER-2021-5683-0918052
Page 223 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918053
Page 224 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918054
Page 225 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0918055
Page 226 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0918056
Page 227 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
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FDA-CBER-2021-5683-0918057
Page 228 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
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FDA-CBER-2021-5683-0918058
Page 229 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0918059
Page 230 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0918060
Page 231 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918061
Page 232 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918062
Page 233 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Oct-20-2020 17:14:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0918063
Page 234 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-20-2020 17:13:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918064
Page 235 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-20-2020 17:13:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918065
Page 236 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-20-2020 17:13:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918066
Page 237 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-20-2020 17:13:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918067
Page 238 of 426
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/20/2020Form: IMAGING - 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: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-20-2020 17:13:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918068
Page 239 of 426
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-26-2021 13:21:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918069
Page 240 of 426
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-08-2021 11:19:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Mar-05-2021 13:12:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-26-2021 13:14:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Jan-25-2021 14:02:47 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918070
Page 241 of 426
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
N/A Jan-25-2021 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Jan-25-2021 10:23:47 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918071
Page 242 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020 08:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020 08:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918072
Page 243 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 08:47:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/16/2020Initial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918073
Page 244 of 426
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020 08:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10571327Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 08:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 08:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 08:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020 08:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918074
Page 245 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 08:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918075
Page 246 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020 08:48:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 08:48:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 08:48:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918076
Page 247 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020 08:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Type II Diabetes
Mellitus
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020 08:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 08:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type II Diabetes MellitusInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020 08:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020 08:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3e21\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-2021-5683-0918077
Page 248 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-19-2020 08:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Chronic Obstructive
Pulmonary Disease
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020 08:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 08:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic Obstructive Pulmonary Di
seaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 08:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020 08:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020 08:59:56
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3e21\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-2021-5683-0918078
Page 249 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
002
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 08:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 08:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 08:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 08:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020 09:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:CholelithiasisInitial Entry
090177e196ae3e21\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-2021-5683-0918079
Page 250 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: UNK/UNK/198
5
Ongoing: NO
End Date:
UNK/UNK/
1985
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CholelithiasisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020 09:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020 09:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
1.e
Date Location User Value Reason
Oct-19-2020 09:00:49
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 5Initial Entry
090177e196ae3e21\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-2021-5683-0918080
Page 251 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) r:
Medical History
Term:Cholecystectom
y
Start Date: UNK/UNK/198
5
Ongoing: NO
End Date:
UNK/UNK/
1985
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CholecystectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020 09:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020 09:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
1.f
090177e196ae3e21\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-2021-5683-0918081
Page 252 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-19-2020 09:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Cesarean Sect
ion
Start Date: Sep/23/2002
Ongoing: NO
End Date:
Sep/23/200
2Initial Entry
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cesarean SectionInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020 09:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2002Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020 09:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/23/2002Initial Entry
090177e196ae3e21\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-2021-5683-0918082
Page 253 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g
Date Location User Value Reason
Oct-19-2020 09:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Cesarean Sect
ion
Start Date: Jul/27/1999
Ongoing: NO
End Date:
Jul/27/199
9Initial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918083
Page 254 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cesarean SectionInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-19-2020 09:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/27/1999Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-19-2020 09:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/27/1999Initial Entry
1.h
Date Location User Value Reason
Oct-19-2020 09:06:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Left Wrist Carpal T
unnel Surgery
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019Initial Entry
090177e196ae3e21\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-2021-5683-0918084
Page 255 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:06:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:06:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Wrist Carpal Tunnel SurgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-19-2020 09:06:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-19-2020 09:06:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.i
Date Location User Value Reason
Oct-19-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Right Wrist Carpal
Tunnel Surgery
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/2020Initial Entry
090177e196ae3e21\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-2021-5683-0918085
Page 256 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.i Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Wrist Carpal Tunnel SurgeryInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-19-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-19-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/UNK/2020Initial Entry
1.j
Date Location User Value Reason
Oct-19-2020 09:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Bilateral Hands Carp
al Tunnel Syndrome
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918086
Page 257 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.j Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral Hands Carpal Tunnel Syn
dromeInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-19-2020 09:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-21-2020 06:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918087
Page 258 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.j Ongoing:
Date Location User Value Reason
Oct-20-2020 17:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered THE SURGERY
DID NOT
RECTIFY THE
CONDITION
Oct-20-2020 14:26:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
carpal tunnel
syndrome is
reported to remain
ongoing despite
surgeries on both
left and right sides.
Please review and
confirm if entry
remains correct
Oct-19-2020 09:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-19-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Myocardial Infa
rction
Start Date: May/28/2017
Ongoing: NO
End Date:
May/28/2017Initial Entry
090177e196ae3e21\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918088
Page 259 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.k Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Myocardial InfarctionInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-19-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/28/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-19-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/28/2017Initial Entry
1.l
Date Location User Value Reason
Oct-19-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Hist
ory Term:Coronary Artery Ste
nt Placement
Start Date: May/28/2017
Ongoing: NO
End Date:
May/28/2017Initial Entry
090177e196ae3e21\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-2021-5683-0918089
Page 260 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary Artery Stent PlacementInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-19-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/28/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-19-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/28/2017Initial Entry
1.m
Date Location User Value Reason
Oct-19-2020 09:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:13
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918090
Page 261 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.m Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-19-2020 09:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-19-2020 09:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Oct-19-2020 09:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History T
erm:Asthma
Start Date: UNK/UNK/1
970
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918091
Page 262 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.n Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-19-2020 09:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.n Ongoing:
Date Location User Value Reason
Oct-19-2020 09:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Oct-19-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History T
erm:Dyslipidemia
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918092
Page 263 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.o Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DyslipidemiaInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-19-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-19-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Oct-19-2020 09:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/2011
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918093
Page 264 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.p Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gastroesophageal Reflux DiseaseInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-19-2020 09:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-19-2020 09:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Oct-19-2020 09:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History T
erm:Depression
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918094
Page 265 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.q Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.q Start Date:
Date Location User Value Reason
Oct-19-2020 09:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.q Ongoing:
Date Location User Value Reason
Oct-19-2020 09:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Oct-19-2020 09:21:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History T
erm:Post Menopa
usal
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918095
Page 266 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.r Line/MH Number:
Date Location User Value Reason
Oct-19-2020 09:21:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 09:21:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Post MenopausalInitial Entry
1.r Start Date:
Date Location User Value Reason
Oct-19-2020 09:21:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.r Ongoing:
Date Location User Value Reason
Oct-19-2020 09:21:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Oct-19-2020 09:21:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History T
erm:Obesity
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3e21\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-2021-5683-0918096
Page 267 of 426
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.s Line/MH Number:
Date Location User
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