125742 S1 M5 CRF c4591001 1111 11111011

Document text

Page 1 of 510
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
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(b) (4)
FDA-CBER-2021-5683-0927266
Page 2 of 510
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/31/2020
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927267
Page 3 of 510
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11111011]
2.Birth Date: 1946
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
WHITE
6.Racial Designation:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0927268
Page 4 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/31/2020
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927269
Page 5 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
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Page 6 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
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(b) (4)
FDA-CBER-2021-5683-0927271
Page 7 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927272
Page 8 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
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(b) (4)
FDA-CBER-2021-5683-0927273
Page 9 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathJul/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0927274
Page 10 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Constipation]
Start Date: UNK/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fatty Liver]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Incontinence]
Start Date: UNK/UNK/2002
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine Fibroids]
Start Date: UNK/UNK/1970
Ongoing: NO
End Date:
UNK/UNK/1988
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927275
Page 11 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anemia]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2020
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Glaucoma]
Start Date: UNK/UNK/2019
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cataracts]
Start Date: UNK/UNK/2019
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MacularDegeneration]
Start Date: UNK/UNK/2019
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tremors]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927276
Page 12 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel syndrome]
Start Date: UNK/UNK/1988
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic neuropathy-hands]
Start Date: UNK/UNK/2000
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acne]
Start Date: UNK/UNK/1960
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rosacea]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1985
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Granuloma annulara]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927277
Page 13 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Basal Skin cancer (back)]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholesterol]
Start Date: UNK/UNK/1985
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteopenia]
Start Date: UNK/UNK/1985
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II Diabetes]
Start Date: UNK/UNK/1985
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927278
Page 14 of 510
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/1985
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: UNK/UNK/1985
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Back pain]
Start Date: UNK/UNK/1980
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/1970
Ongoing: YES
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927279
Page 15 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Jul/31/2020
2.Weight: [151.4]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [28.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927280
Page 16 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927281
Page 17 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/31/2020
2.Randomization Number: [221155]
3.Randomization Group: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927282
Page 18 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5CMT]
5.bSample ID [BP5CMV]
5.cSample ID [BP5CMW]
5.dSample ID [BLD2JV]
5.eSample ID [BLD2JW]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927283
Page 19 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5CMX]
5.bSample ID [BP5CMV ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927284
Page 20 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: Jul/31/2020 15:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927285
Page 21 of 510
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927286
Page 22 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927287
Page 23 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927288
Page 24 of 510
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927289
Page 25 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927290
Page 26 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927291
Page 27 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5CHB]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927292
Page 28 of 510
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 11:31
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
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927293
Page 29 of 510
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927294
Page 30 of 510
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927295
Page 31 of 510
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927296
Page 32 of 510
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPYB4G]
5.bSample ID [BPYB4H]
5.cSample ID [BPYB4J]
5.dSample ID [BNW9CV]
5.eSample ID [BNW9CW]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927297
Page 33 of 510
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927298
Page 34 of 510
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BP9R49]
5.bSample ID [BP9R4B]
5.cSample ID [BP9R4C]
5.dSample ID [BRTHXR]
5.eSample ID [BRTHXS]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927299
Page 35 of 510
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927300
Page 36 of 510
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927301
Page 37 of 510
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927302
Page 38 of 510
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927303
Page 39 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927304
Page 40 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927305
Page 41 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4 hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927306
Page 42 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable
 Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927307
Page 43 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927308
Page 44 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927309
Page 45 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927310
Page 46 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927311
Page 47 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927312
Page 48 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927313
Page 49 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927314
Page 50 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927315
Page 51 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927316
Page 52 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927317
Page 53 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927318
Page 54 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927319
Page 55 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927320
Page 56 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927321
Page 57 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927322
Page 58 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927323
Page 59 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927324
Page 60 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927325
Page 61 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927326
Page 62 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927327
Page 63 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927328
Page 64 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927329
Page 65 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927330
Page 66 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927331
Page 67 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927332
Page 68 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927333
Page 69 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927334
Page 70 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927335
Page 71 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927336
Page 72 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927337
Page 73 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927338
Page 74 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927339
Page 75 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927340
Page 76 of 510
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927341
Page 77 of 510
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/24/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927342
Page 78 of 510
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/24/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927343
Page 79 of 510
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/24/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/24/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIARY
3.Comments: [Subject stated she filled out COVID illness diary as yes in error]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927344
Page 80 of 510
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927345
Page 81 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927346
Page 82 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927347
Page 83 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927348
Page 84 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Heart palpitations  Aug/26/2020 UN
K:UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Increase glucose lev
el Aug/22/2020 UN
K:UNK NO
End Date Time:
Sep/17/2020 UNK:UN
K
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Infected tooth bridg
e Dec/2/2020 UNK:
UNK NO
End Date Time:
Dec/9/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EV
ENT 4  Swollen lymph node
(neck) Dec/2/2020 UNK:
UNK NO
End Date Time:
Dec/9/2020 UNK:UNK
 Repeating
Pages
 5.ADVERSE EV
ENT 5  Infected tooth bridg
e Feb/5/2021 UNK:
UNK NO
End Date Time:
Feb/12/2021 UNK:UN
K
 Repeating
Pages
 6.ADVERSE EV
ENT 6  Swollen lymph node
(neck) Feb/5/2021 UNK:
UNK NO
End Date Time:
Feb/12/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927349
Page 85 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Heart palpitations]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927350
Page 86 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927351
Page 87 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Increase glucose level]
4.Start Date Time: Aug/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/17/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927352
Page 88 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927353
Page 89 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Infected tooth bridge]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown etiology]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927354
Page 90 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927355
Page 91 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Swollen lymph node (neck)]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927356
Page 92 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927357
Page 93 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Infected tooth bridge]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927358
Page 94 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927359
Page 95 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Swollen lymph node (neck)]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927360
Page 96 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927361
Page 97 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927362
Page 98 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927363
Page 99 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medic
ationStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  FLUAD Quadri
valent Sep/22/2
020 Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927364
Page 100 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[FLUAD Quadrivalent]
5.Date: Sep/22/2020
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927365
Page 101 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927366
Page 102 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927367
Page 103 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927368
Page 104 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927369
Page 105 of 510
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927370
Page 106 of 510
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927371
Page 107 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927372
Page 108 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927373
Page 109 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927374
Page 110 of 510
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927375
Page 111 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927376
Page 112 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927377
Page 113 of 510
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927378
Page 114 of 510
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927379
Page 115 of 510
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927380
Page 116 of 510
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927381
Page 117 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927382
Page 118 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927383
Page 119 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927384
Page 120 of 510
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927385
Page 121 of 510
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927386
Page 122 of 510
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/18/2020
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927387
Page 123 of 510
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927388
Page 124 of 510
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Stephens Approved Feb-24-2021 14:51:50 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, 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.
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0927389
Page 125 of 510
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-21-2020 12:40:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927390
Page 126 of 510
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-21-2020 12:40:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927391
Page 127 of 510
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-21-2020 12:40:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927392
Page 128 of 510
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-21-2020 12:40:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927393
Page 129 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:45:12 (UTC-05:00) Eastern
Time (US & Canada)created in error
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927394
Page 130 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927395
Page 131 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927396
Page 132 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927397
Page 133 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927398
Page 134 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.aAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927399
Page 135 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.bAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927400
Page 136 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.cAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927401
Page 137 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.dAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927402
Page 138 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.eAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927403
Page 139 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 fAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927404
Page 140 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.gAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927405
Page 141 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 hAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927406
Page 142 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.iAug-25-2020 08:51:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927407
Page 143 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927408
Page 144 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927409
Page 145 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927410
Page 146 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927411
Page 147 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927412
Page 148 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927413
Page 149 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927414
Page 150 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927415
Page 151 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927416
Page 152 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Aug-25-2020 08:51:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927417
Page 153 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:51:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927418
Page 154 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 08:51:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927419
Page 155 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 08:51:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927420
Page 156 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 08:51:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927421
Page 157 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 08:51:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927422
Page 158 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:52:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927423
Page 159 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 08:52:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927424
Page 160 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 08:52:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927425
Page 161 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 08:52:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927426
Page 162 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 08:52:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927427
Page 163 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927428
Page 164 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.aAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927429
Page 165 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.bAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927430
Page 166 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.cAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927431
Page 167 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.dAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927432
Page 168 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.eAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927433
Page 169 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1 fAug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927434
Page 170 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927435
Page 171 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 08:52:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927436
Page 172 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927437
Page 173 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927438
Page 174 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927439
Page 175 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927440
Page 176 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927441
Page 177 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927442
Page 178 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Aug-25-2020 09:00:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927443
Page 179 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-22-2020 14:15:15 (UTC-05:00) Eastern
Time (US & Canada)form created in error
Not Applicable
FormOct-22-2020 12:57:53 (UTC-05:00) Eastern
Time (US & Canada)
FormAug-25-2020 09:00:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927444
Page 180 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-22-2020 14:15:15 (UTC-05:00) Eastern
Time (US & Canada)form created in error
Not Applicable
1Oct-22-2020 12:57:53 (UTC-05:00) Eastern
Time (US & Canada)
1Aug-25-2020 09:00:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927445
Page 181 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-22-2020 14:15:15 (UTC-05:00) Eastern
Time (US & Canada)form created in error
Not Applicable
2Oct-22-2020 12:57:53 (UTC-05:00) Eastern
Time (US & Canada)
2Aug-25-2020 09:00:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927446
Page 182 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-22-2020 14:15:15 (UTC-05:00) Eastern
Time (US & Canada)form created in error
Not Applicable
3Oct-22-2020 12:57:53 (UTC-05:00) Eastern
Time (US & Canada)
3Aug-25-2020 09:00:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927447
Page 183 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927448
Page 184 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927449
Page 185 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927450
Page 186 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927451
Page 187 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927452
Page 188 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927453
Page 189 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927454
Page 190 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927455
Page 191 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927456
Page 192 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927457
Page 193 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927458
Page 194 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927459
Page 195 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927460
Page 196 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927461
Page 197 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927462
Page 198 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927463
Page 199 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927464
Page 200 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927465
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927466
Page 202 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927467
Page 203 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927468
Page 204 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927469
Page 205 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927470
Page 206 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927471
Page 207 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927472
Page 208 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927473
Page 209 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927474
Page 210 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927475
Page 211 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927476
Page 212 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927477
Page 213 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927478
Page 214 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927479
Page 215 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927480
Page 216 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927481
Page 217 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927482
Page 218 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927483
Page 219 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927484
Page 220 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:01:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927485
Page 221 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927486
Page 222 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927487
Page 223 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927488
Page 224 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927489
Page 225 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927490
Page 226 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927491
Page 227 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927492
Page 228 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927493
Page 229 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927494
Page 230 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927495
Page 231 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927496
Page 232 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927497
Page 233 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927498
Page 234 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927499
Page 235 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927500
Page 236 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927501
Page 237 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927502
Page 238 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927503
Page 239 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927504
Page 240 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927505
Page 241 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927506
Page 242 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927507
Page 243 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927508
Page 244 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927509
Page 245 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927510
Page 246 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927511
Page 247 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927512
Page 248 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927513
Page 249 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927514
Page 250 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927515
Page 251 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927516
Page 252 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927517
Page 253 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927518
Page 254 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927519
Page 255 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927520
Page 256 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927521
Page 257 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927522
Page 258 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927523
Page 259 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927524
Page 260 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927525
Page 261 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927526
Page 262 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927527
Page 263 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927528
Page 264 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927529
Page 265 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jAug-25-2020 09:05:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927530
Page 266 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927531
Page 267 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927532
Page 268 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aAug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927533
Page 269 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aAug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927534
Page 270 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aAug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927535
Page 271 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aAug-25-2020 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927536
Page 272 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:05:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927537
Page 273 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:05:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927538
Page 274 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aAug-25-2020 09:05:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927539
Page 275 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 09:05:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927540
Page 276 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-25-2020 09:05:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927541
Page 277 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-25-2020 09:05:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927542
Page 278 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-25-2020 09:05:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e4f\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0927543
Page 279 of 510
***Confidential***
Header Text: c4591001
Visit: POT_COVI
…[truncated]