125742 S1 M5 CRF c4591001 1111 11111103

Document text

Page 1 of 906
***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: 11111103 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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928707
Page 2 of 906
***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: 11111103 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
Aug/11/2020
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928708
Page 3 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11111103]
2.Birth Date: 1954
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928709
Page 4 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928710
Page 5 of 906
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928711
Page 6 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928712
Page 7 of 906
***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: 11111103 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:[diverticulosis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[benign prostatic hypertrophy]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[low libido]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928713
Page 8 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vitamin d deficiency]
Start Date: UNK/UNK/2010
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[nearsighted]
Start Date: UNK/UNK/2004
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[farsighted]
Start Date: UNK/UNK/2004
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[fungus toenail]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928714
Page 9 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis-hips]
Start Date: UNK/UNK/2013
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[total hip replacement right]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[total hip replacement left]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928715
Page 10 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[dyslipidemia]
Start Date: UNK/UNK/1997
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypothyroidism]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928716
Page 11 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [214.4]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [32.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928717
Page 12 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [226116]
3.Randomization Group: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928718
Page 13 of 906
***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: 11111103 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:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5CB8]
5.bSample ID [BP5CB9]
5.cSample ID [BP5CBB]
5.dSample ID [BLD2RX]
5.eSample ID [BLD2RY]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928719
Page 14 of 906
***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: 11111103 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/11/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5CBC]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928720
Page 15 of 906
***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: 11111103 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/11/2020 18:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928721
Page 16 of 906
***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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928722
Page 17 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928723
Page 18 of 906
***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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928724
Page 19 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928725
Page 20 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928726
Page 21 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928727
Page 22 of 906
***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: 11111103 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/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 [BPY9XT]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928728
Page 23 of 906
***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: 11111103 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/31/2020 08:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928729
Page 24 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928730
Page 25 of 906
***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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928731
Page 26 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928732
Page 27 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928733
Page 28 of 906
***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: 11111103 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9RDC]
5.bSample ID [BP9RDD]
5.cSample ID [BP9RDF]
5.dSample ID [BNW9GP]
5.eSample ID [BNW9GR]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928734
Page 29 of 906
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928735
Page 30 of 906
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 11111103 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:
Mar/8/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRNVKJ]
5.bSample ID [BRNVKK]
5.cSample ID [BRNVKL]
5.dSample ID [BNWPM9]
5.eSample ID [BNWPMB]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928736
Page 31 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928737
Page 32 of 906
***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: 11111103 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 [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928738
Page 33 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928739
Page 34 of 906
***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: 11111103 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 [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928740
Page 35 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928741
Page 36 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/22/2020
2.Date of First Symptom
Started:Sep/13/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928742
Page 37 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Dry cough (intermittent but not new) ]
5.cSymptoms - Other Text: [Post-nasal drip]
5.dSymptoms - Other Text: [Anemia]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928743
Page 38 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Loc
ationAssay Code and Descri
ptionDevice TypeForm Insta
nce
 1.Oct/17/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTIC
TEST Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928744
Page 39 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/17/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection
Location:NASOPHARYNX Comments
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: QUIDEL CORPORATION LYRA SARS-COV-2
ASSAYComments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928745
Page 40 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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_SELF
3.Sample Collected? YES
Date of Collection:
Sep/20/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV10942]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928746
Page 41 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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? NO
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[self swab was submitted]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928747
Page 42 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928748
Page 43 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ] Comments
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928749
Page 44 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928750
Page 45 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928751
Page 46 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2 Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928752
Page 47 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity Gr
adeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928753
Page 48 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done Comments
2.Subcategory of Clinical
Event:Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928754
Page 49 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done 
Not Done  Not
Done Not
Done Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928755
Page 50 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928756
Page 51 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928757
Page 52 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928758
Page 53 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928759
Page 54 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928760
Page 55 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928761
Page 56 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928762
Page 57 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
 1.Not Done  Not Done  Not Don
e Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928763
Page 58 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928764
Page 59 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928765
Page 60 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928766
Page 61 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928767
Page 62 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928768
Page 63 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928769
Page 64 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928770
Page 65 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928771
Page 66 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928772
Page 67 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928773
Page 68 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928774
Page 69 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date: Vital Signs Details Form Instance
 1.Unknown Record Identifier: Systolic: Diastolic:
Not Done  Unknown  Unknown Repeating Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928775
Page 70 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: Unknown
1
Systolic: Unknown
[ ]Comments
Diastolic: Unknown
[ ]Comments
Respiratory Rate in
respirations/minute:Unknown
[ ]Comments
Heart Rate in
beats/minute:Unknown
[ ]Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928776
Page 71 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928777
Page 72 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928778
Page 73 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928779
Page 74 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928780
Page 75 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not D
one Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928781
Page 76 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928782
Page 77 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessm
entLocation of Assess
mentImaging Meth
odOverall Assessm
entForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928783
Page 78 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928784
Page 79 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928785
Page 80 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928786
Page 81 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
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
[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928787
Page 82 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of C
ollectionSpecime
n TypeSpecimen Colle
ction LocationAssay Code an
d DescriptionDevice
TypeForm Instan
ce
 1. DELETED Not Done  Not Don
e Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928788
Page 83 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928789
Page 84 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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.aSample ID Not Applicable
[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928790
Page 85 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928791
Page 86 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928792
Page 87 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
3.Has the subject been
hospitalized due to potential
COVID-19 illness?Not Applicable Comments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928793
Page 88 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Id
entifierCon Non-Drug Treatmen
ts Pre-specifiedTreatmen
tTreatmen
tStart Dat
eForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928794
Page 89 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928795
Page 90 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928796
Page 91 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity Gr
adeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928797
Page 92 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928798
Page 93 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor
NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
 1.Not Applic
able Not App
licable Not App
licable Not App
licable Sponsor-Defi
ned Identifie
rTest:Result:
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 
Not Applicabl
e Not
Done
 Not Ap
plicable
 Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928799
Page 94 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
AddressNot 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928800
Page 95 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928801
Page 96 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928802
Page 97 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928803
Page 98 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928804
Page 99 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928805
Page 100 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928806
Page 101 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category
for Lab T
estVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Applic
able Not Applicab
le Not Ap
plicable Not Ap
plicable
 Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928807
Page 102 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category
for Lab T
estVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
Not Applica
ble Not
Done
 Not Ap
plicabl
e 
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928808
Page 103 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
AddressNot 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928809
Page 104 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928810
Page 105 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928811
Page 106 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928812
Page 107 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928813
Page 108 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928814
Page 109 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928815
Page 110 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928816
Page 111 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928817
Page 112 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928818
Page 113 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 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 Done  Not Applicable  Not Applicable Repeating Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928819
Page 114 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928820
Page 115 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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 Done  Not Applicable Repeating Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928821
Page 116 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928822
Page 117 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928823
Page 118 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928824
Page 119 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart D
ateForm Instan
ce
 1.Not Applicable
 Not Applicabl
e Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928825
Page 120 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928826
Page 121 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessm
entLocation of Assess
mentImaging Meth
odOverall Assessm
entForm Instance
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applicable  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928827
Page 122 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Oct/15/2020Form: 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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928828
Page 123 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/20/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928829
Page 124 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 11111103 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:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY9MS]
5.bSample ID [BPY9MT]
5.cSample ID [BPY9MV]
5.dSample ID [BRTHBH]
5.eSample ID [BRTHBJ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928830
Page 125 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928831
Page 126 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928832
Page 127 of 906
***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: 11111103 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928833
Page 128 of 906
***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: 11111103 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: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928834
Page 129 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
1 - Unscheduled Visit on Oct/15/2020Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: COVID_AR1
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928835
Page 130 of 906
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
1 - Unscheduled Visit on Oct/15/2020Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV27289]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928836
Page 131 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Endocarditis  Feb/16/2021 U
NK:UNK NO
End Date Time:
Feb/27/2021 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  Dyspnea on exert
ion Feb/UNK/202
1 UNK:UNK NO
End Date Time:
Feb/27/2021 UN
K:UNK
 Repeating
Pages
 3.ADVERS
E EVENT 3  Bacteremia  Feb/16/2021 U
NK:UNK NO
End Date Time:
Feb/27/2021 UN
K:UNK
 Repeating
Pages
 4.ADVERS
E EVENT 4  Anemia  Oct/12/2020 U
NK:UNK YES  Repeating
Pages
 5.ADVERS
E EVENT 5  Lower extremity
edema Oct/UNK/202
0 UNK:UNK NO
End Date Time:
Feb/27/2021 UN
K:UNK
 Repeating
Pages
 6.ADVERS
E EVENT 6  Purpuric rash on
lower extremity Oct/UNK/202
0 UNK:UNK NO
End Date Time:Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928837
Page 132 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
Feb/27/2021 UN
K:UNK
 
 7.ADVERS
E EVENT 7  Elevated liver fu
nction tests Nov/UNK/202
0 UNK:UNK NO
End Date Time:
Feb/27/2021 UN
K:UNK
 Repeating
Pages
 8.ADVERS
E EVENT 8  Splenic infarcts  Feb/16/2021 U
NK:UNK YES  Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928838
Page 133 of 906
***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: 11111103 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)[Endocarditis]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928839
Page 134 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[bacteremia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928840
Page 135 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[2021201239]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928841
Page 136 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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)[Dyspnea on exertion]
4.Start Date Time: Feb/UNK/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928842
Page 137 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[endocarditis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928843
Page 138 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[2021201239]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928844
Page 139 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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)[Bacteremia]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928845
Page 140 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928846
Page 141 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[2021201239]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928847
Page 142 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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)[Anemia]
4.Start Date Time: Oct/12/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928848
Page 143 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928849
Page 144 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928850
Page 145 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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)[Lower extremity edema]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928851
Page 146 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[bacteremia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928852
Page 147 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928853
Page 148 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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)[Purpuric rash on lower extremity]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928854
Page 149 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Bacteremia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928855
Page 150 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928856
Page 151 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Elevated liver function tests]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928857
Page 152 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928858
Page 153 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928859
Page 154 of 906
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Splenic infarcts]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928860
Page 155 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Bacteremia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928861
Page 156 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928862
Page 157 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication E
rrors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928863
Page 158 of 906
***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: 11111103 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[ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928864
Page 159 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928865
Page 160 of 906
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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.Date: //
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928866
Page 161 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928867
Page 162 of 906
***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: 11111103 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?
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928868
Page 163 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928869
Page 164 of 906
***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: 11111103 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?
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928870
Page 165 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928871
Page 166 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928872
Page 167 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928873
Page 168 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11111103 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:
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928874
Page 169 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11111103 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?
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928875
Page 170 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928876
Page 171 of 906
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928877
Page 172 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928878
Page 173 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928879
Page 174 of 906
***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: 11111103 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 [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928880
Page 175 of 906
***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: 11111103 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 [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928881
Page 176 of 906
***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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928882
Page 177 of 906
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928883
Page 178 of 906
***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: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928884
Page 179 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928885
Page 180 of 906
***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: 11111103 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: [ ]
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928886
Page 181 of 906
***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: 11111103 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/28/2020
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928887
Page 182 of 906
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928888
Page 183 of 906
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928889
Page 184 of 906
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-11-2020 19:27:20
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928890
Page 185 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
FormSep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928891
Page 186 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
1Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928892
Page 187 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
2Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928893
Page 188 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
3Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928894
Page 189 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
4Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928895
Page 190 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
5Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928896
Page 191 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
6Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928897
Page 192 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
7Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928898
Page 193 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
8Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928899
Page 194 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Oct-20-2020 13:00:54 (UTC-05:00)
Eastern Time (US & Canada)
9Sep-23-2020 12:54:08 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928900
Page 195 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-07-2020 11:13:45 (UTC-05:00)
Eastern Time (US & Canada)
2Sep-23-2020 13:03:00 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928901
Page 196 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928902
Page 197 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928903
Page 198 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928904
Page 199 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928905
Page 200 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928906
Page 201 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928907
Page 202 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Sep-28-2020 10:03:05 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928908
Page 203 of 906
***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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-30-2020 16:15:32 (UTC-05:00)
Eastern Time (US & Canada)
3Sep-28-2020 09:59:53 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928909
Page 204 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 10:11:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
FormSep-28-2020 10:11:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928910
Page 205 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-28-2020 10:11:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
1Sep-28-2020 10:11:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928911
Page 206 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-28-2020 10:11:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
2Sep-28-2020 10:11:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928912
Page 207 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-28-2020 10:11:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
3Sep-28-2020 10:11:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928913
Page 208 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 10:11:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
4Sep-28-2020 10:11:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928914
Page 209 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928915
Page 210 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928916
Page 211 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928917
Page 212 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928918
Page 213 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928919
Page 214 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928920
Page 215 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928921
Page 216 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928922
Page 217 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928923
Page 218 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928924
Page 219 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928925
Page 220 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928926
Page 221 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928927
Page 222 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928928
Page 223 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928929
Page 224 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928930
Page 225 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928931
Page 226 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928932
Page 227 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928933
Page 228 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928934
Page 229 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928935
Page 230 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928936
Page 231 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928937
Page 232 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928938
Page 233 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928939
Page 234 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928940
Page 235 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928941
Page 236 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928942
Page 237 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928943
Page 238 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928944
Page 239 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928945
Page 240 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928946
Page 241 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:11:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928947
Page 242 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928948
Page 243 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928949
Page 244 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928950
Page 245 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928951
Page 246 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928952
Page 247 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928953
Page 248 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928954
Page 249 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928955
Page 250 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928956
Page 251 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928957
Page 252 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928958
Page 253 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928959
Page 254 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928960
Page 255 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928961
Page 256 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928962
Page 257 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928963
Page 258 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928964
Page 259 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928965
Page 260 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928966
Page 261 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928967
Page 262 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928968
Page 263 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928969
Page 264 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928970
Page 265 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928971
Page 266 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928972
Page 267 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928973
Page 268 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928974
Page 269 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928975
Page 270 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928976
Page 271 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928977
Page 272 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928978
Page 273 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928979
Page 274 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928980
Page 275 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928981
Page 276 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928982
Page 277 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928983
Page 278 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928984
Page 279 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020Form: 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: 11111103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iSep-28-2020 10:12:09 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4d\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928985
Page 280 of 906
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/22/2020F
…[truncated]