Document text
Page 1 of 357
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800095
Page 2 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/29/2020
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800096
Page 3 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291005]
2.Birth Date: /1970
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:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800097
Page 4 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/29/2020
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800098
Page 5 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with
the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800099
Page 6 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800100
Page 7 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study
entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800101
Page 8 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathJul/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800102
Page 9 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1980
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: Mar/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[constipation]
Start Date: May/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Roux-en-Y gastric bypass]
Start Date: Mar/20/2020
Ongoing: NO
End Date:
Mar/20/2020
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800103
Page 10 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fatty Liver Disease]
Start Date: UNK/UNK/2005
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin B12 deficiency]
Start Date: UNK/UNK/2018
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vitamin D deficiency]
Start Date: UNK/UNK/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nearsighted]
Start Date: UNK/UNK/1970
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[macular dystrophy left eye]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800104
Page 11 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hole in Retina]
Start Date: UNK/UNK/2019
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right Carpal tunnel syndrome]
Start Date: UNK/UNK/1990
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic neuropathy]
Start Date: UNK/UNK/2017
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/2010
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dermatitis of the scalp]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800105
Page 12 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Trigger finger]
Start Date: UNK/UNK/2010
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[type ii diabetes mellitus]
Start Date: UNK/UNK/2017
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High cholesterol]
Start Date: UNK/UNK/2018
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overweight]
Start Date: UNK/UNK/1995
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right bundle branch block]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800106
Page 13 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ST depression]
Start Date: UNK/UNK/2010
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: Jan/UNK/2019
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[repaired hole in retina]
Start Date: UNK/UNK/2019
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[smoker]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
Mar/UNK/2020
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800107
Page 14 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Jul/29/2020
2.Weight: [229.6]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [36.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800108
Page 15 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/29/2020
2.Randomization Number: [40184]
3.Randomization Group: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800109
Page 16 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
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 [BP5PV2]
5.bSample ID [BP5PV4]
5.cSample ID [BP5PV3]
5.dSample ID [BLD15B]
5.eSample ID [BLD159]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800110
Page 17 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
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 [BP5PPH]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800111
Page 18 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jul/29/2020 14:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800112
Page 19 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800113
Page 20 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800114
Page 21 of 357
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800115
Page 22 of 357
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800116
Page 23 of 357
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800117
Page 24 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMB575]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800118
Page 25 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/18/2020 16:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800119
Page 26 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800120
Page 27 of 357
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800121
Page 28 of 357
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800122
Page 29 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[sample documented under COVID illness visit occurred at the same time as a
scheduled visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN698D]
5.bSample ID [BN698F]
5.cSample ID [BN698G]
5.dSample ID [BLD18P]
5.eSample ID [BLD18R]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800123
Page 30 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800124
Page 31 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BTZPLN]
5.bSample ID [BTZPL7]
5.cSample ID [BTZPL8]
5.dSample ID [BSFMXG]
5.eSample ID [BSFMXH]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800125
Page 32 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800126
Page 33 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800127
Page 34 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800128
Page 35 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800129
Page 36 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800130
Page 37 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: CONTACT OUTCOME
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEHEALTH VISIT
2.Was contact made? YES
Date of Contact:
Aug/10/2020
3.Comments: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800131
Page 38 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/10/2020
2.Date of First Symptom Started: Aug/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Aug/21/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800132
Page 39 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800133
Page 40 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800134
Page 41 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Aug/10/2020
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 [CV28744]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800135
Page 42 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
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 acquired see self swab ECRF page]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800136
Page 43 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800137
Page 44 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatment Treatment Start Date Form Instance
1. DELETED Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800138
Page 45 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800139
Page 46 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800140
Page 47 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800141
Page 48 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800142
Page 49 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. [ ] Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800143
Page 50 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800144
Page 51 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800145
Page 52 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800146
Page 53 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800147
Page 54 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800148
Page 55 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800149
Page 56 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800150
Page 57 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800151
Page 58 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800152
Page 59 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800153
Page 60 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800154
Page 61 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800155
Page 62 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800156
Page 63 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800157
Page 64 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/19/2020
2.Date of First Symptom Started: Oct/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/3/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [increased nasal congestion]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800158
Page 65 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.bSymptoms - Other Text: [wife tested positive for covid 19 ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800159
Page 66 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/19/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800160
Page 67 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/19/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800161
Page 68 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV17493]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800162
Page 69 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 taken]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800163
Page 70 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800164
Page 71 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800165
Page 72 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800166
Page 73 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: 1
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800167
Page 74 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800168
Page 75 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800169
Page 76 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800170
Page 77 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800171
Page 78 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800172
Page 79 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800173
Page 80 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800174
Page 81 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800175
Page 82 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800176
Page 83 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800177
Page 84 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800178
Page 85 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800179
Page 86 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800180
Page 87 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800181
Page 88 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800182
Page 89 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800183
Page 90 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Sep/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800184
Page 91 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Sep/15/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BN698D]
5.bSample ID [BN698F]
5.cSample ID [BN698G]
5.dSample ID [BLD18P]
5.eSample ID [BLD18R]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800185
Page 92 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Nov/17/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800186
Page 93 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMPP3C]
5.bSample ID [BMPP3D]
5.cSample ID [BR6XZ8]
5.dSample ID [BR6XZ7]
5.eSample ID [BR6XZ6]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800187
Page 94 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/10/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800188
Page 95 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/10/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800189
Page 96 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/10/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/10/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800190
Page 97 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/10/2020Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800191
Page 98 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/20/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800192
Page 99 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/20/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800193
Page 100 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/20/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/20/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800194
Page 101 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800195
Page 102 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800196
Page 103 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800197
Page 104 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800198
Page 105 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# CategoryAE Identif
ierAdverse Eve
ntStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1. DELETED ADVERSE EV
ENT 1 headache Jul/29/2020 14:12 NO
End Date Time:
Jul/29/2020 14:22
Repeating
Pages
2. ADVERSE EV
ENT 2 bowel obstruc
tion Jan/21/2021 UNK:
UNK NO
End Date Time:
Jan/22/2021 UNK:UNK
Repeating
Pages
3. ADVERSE EV
ENT 3 Internal Herni
a Jan/21/2021 10:55 NO
End Date Time:
Jan/22/2021 UNK:UNK
Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800199
Page 106 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[headache]
4.Start Date Time: Jul/29/2020 14:12
5.Is the adverse event still ongoing? NO
End Date Time:
Jul/29/2020 14:22
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800200
Page 107 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800201
Page 108 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[bowel obstruction]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 UNK:UNK
6.Toxicity Grade: 4
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
NOComments
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]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800202
Page 109 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021087081]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800203
Page 110 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Internal Hernia]
4.Start Date Time: Jan/21/2021 10:55
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[etiology previous surgery]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800204
Page 111 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021087081]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800205
Page 112 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800206
Page 113 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800207
Page 114 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800208
Page 115 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: //
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800209
Page 116 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800210
Page 117 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800211
Page 118 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800212
Page 119 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800213
Page 120 of 357
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800214
Page 121 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800215
Page 122 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800216
Page 123 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800217
Page 124 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800218
Page 125 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800219
Page 126 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800220
Page 127 of 357
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800221
Page 128 of 357
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800222
Page 129 of 357
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800223
Page 130 of 357
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800224
Page 131 of 357
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800225
Page 132 of 357
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800226
Page 133 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800227
Page 134 of 357
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800228
Page 135 of 357
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800229
Page 136 of 357
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/15/2020
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800230
Page 137 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800231
Page 138 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800232
Page 139 of 357
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormOct-07-2020 17:16:50 (UTC-05:00) Eastern Time
(US & Canada)sample documented under COVID illness visit
occurred at the same time as a scheduled visit
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800233
Page 140 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800234
Page 141 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800235
Page 142 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800236
Page 143 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800237
Page 144 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800238
Page 145 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800239
Page 146 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800240
Page 147 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
7Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800241
Page 148 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
8Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800242
Page 149 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
9Aug-20-2020 15:31:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800243
Page 150 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-26-2020 15:54:17 (UTC-05:00) Eastern Time
(US & Canada)Self swab acquired see self swab ECRF page. Not
applicable
FormAug-26-2020 15:52:29 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800244
Page 151 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormAug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormAug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
FormAug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800245
Page 152 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
1Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800246
Page 153 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
2Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800247
Page 154 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
3Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800248
Page 155 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
4Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800249
Page 156 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
5Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
5Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800250
Page 157 of 357
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Aug-20-2020 15:36:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
6Aug-20-2020 15:32:15 (UTC-05:00) Eastern Time
(US & Canada)
6Aug-19-2020 18:09:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800251
Page 158 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/10/2020Form: VITAL SIGNS - TEMP - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormSep-01-2020 15:18:05 (UTC-05:00) Eastern Time
(US & Canada)Alex Hill Per note no fever. Patient visit conducted via
telephone.
Not Done
FormAug-31-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800252
Page 159 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Sep-01-2020 15:18:05 (UTC-05:00) Eastern Time
(US & Canada)Alex Hill Per note no fever. Patient visit conducted via
telephone.
Not Done
1Aug-31-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800253
Page 160 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2.aSep-01-2020 15:18:05 (UTC-05:00) Eastern Time
(US & Canada)Alex Hill Per note no fever. Patient visit conducted via
telephone.
Not Done
2.aAug-31-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800254
Page 161 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2.aSep-01-2020 15:18:05 (UTC-05:00) Eastern Time
(US & Canada)Alex Hill Per note no fever. Patient visit conducted via
telephone.
Not Done
2.aAug-31-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800255
Page 162 of 357
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2.aSep-01-2020 15:18:05 (UTC-05:00) Eastern Time
(US & Canada)Alex Hill Per note no fever. Patient visit conducted via
telephone.
Not Done
2.aAug-31-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800256
Page 163 of 357
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
7Mar-09-2021 13:22:04 (UTC-05:00) Eastern Time
(US & Canada)Critical findings were found on the CT Scan 1/21/21
at 15:14, surgical team contacted same day on
1/21/21. Patient was brought to the OR urgently and
surgery note completed by 19:00. Urgent
intervention indicated
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800257
Page 164 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-02-2021 16:26:54 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Nov-25-2020 13:47:54 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-23-2020 17:13:35 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Nov-01-2020 11:55:27 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-29-2020 13:00:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800258
Page 165 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
N/A
Michael Koren Approved Oct-29-2020 08:25:52 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-28-2020 12:05:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Oct-28-2020 11:20:53 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-28-2020 11:00:24 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Oct-14-2020 09:37:20 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800259
Page 166 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Alex Hill N/A Oct-06-2020 19:05:44 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Sep-16-2020 13:25:44 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-15-2020 12:46:55 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Sep-01-2020 16:20:12 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Aug-31-2020 15:04:55 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800260
Page 167 of 357
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
N/A
Michael Koren Approved Aug-26-2020 20:12:37 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800261
Page 168 of 357
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-29-2020 15:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-29-2020 15:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800262
Page 169 of 357
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-29-2020 15:19:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/29/2020Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800263
Page 170 of 357
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-29-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11291005Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-29-2020 15:16:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-29-2020 15:20:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-29-2020 15:20:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-29-2020 15:20:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800264
Page 171 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-29-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/29/2020Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800265
Page 172 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 an
d 85 years, inclusive, at ran
domization (dependent upo
n study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizat
ion (dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800266
Page 173 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with a
ll scheduled visits, vaccinat
ion plan, laboratory tests, li
festyle considerations, and
other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800267
Page 174 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Inclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study p
roceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical hi
story, physical examination
, and clinical judgment of t
he investigator to be eligibl
e for inclusion in the study
Criteri
on met
?:YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800268
Page 175 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclus
ion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800269
Page 176 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance
with the requirements and r
estrictions listed in the ICD
and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800270
Page 177 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increas
e the risk of study participat
ion
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or ac
tive suicidal ideation/behavior/lab ab
normality that may increase the risk
of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800271
Page 178 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vir
us (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800272
Page 179 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.b Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis)
to any component of the st
udy intervention(s)
Criteri
on met
?:NOInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800273
Page 180 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on ID:
(For Pf
izer us
e only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800274
Page 181 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800275
Page 182 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical e
xamination
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals wi
th known or suspected immunodefici
ency, as determined by history and/o
r laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800276
Page 183 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramus
cular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800277
Page 184 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that w
ould, in the opinion of the investigat
or, contraindicate intramuscular injec
tionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are p
regnant or breastfe
eding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800278
Page 185 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800279
Page 186 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agent
s or systemic corticoster
oids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800280
Page 187 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.i Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agen
ts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Desc
ription:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study
intervention administration
or planned receipt through
out the study
Criteri
on met
?:NOInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800281
Page 188 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on ID:
(For Pf
izer use
only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration o
r planned receipt throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800282
Page 189 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
2.k
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days prio
r to study entry and/or dur
ing study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800283
Page 190 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.k Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX16A01Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800284
Page 191 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.l Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other studie
s involving study intervention contai
ning lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise sup
ervised by the investigator,
and their respective family
members
Criteri
on met
?:NOInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800285
Page 192 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 15:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800286
Page 193 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-29-2020 15:22:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-29-2020 15:22:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-29-2020 15:22:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800287
Page 194 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 09:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:1
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/19
80
Ongoing: YESTranscription Error
Jul-29-2020 15:26:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:26:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:26:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-31-2020 09:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Transcription Error
Jul-29-2020 15:26:32
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800288
Page 195 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US & Canada)
1.a Ongoing:
Date Location User Value Reason
Jul-29-2020 15:26:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jul-31-2020 09:16:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Gastroesophageal r
eflux disease
Start Date: Mar/UNK/2020
Ongoing: YESTranscription Error
Jul-29-2020 15:31:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Gastroesophageal r
eflux disease
Start Date: Mar/3/2020
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800289
Page 196 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:31:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:31:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-31-2020 09:16:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Transcription Error
Jul-29-2020 15:31:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-29-2020 15:31:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jul-29-2020 15:33:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:constipation
Start Date: May/UNK/202
0
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800290
Page 197 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:33:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:33:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
constipationInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-29-2020 15:33:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-29-2020 15:33:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-29-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Hemorrhoids
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800291
Page 198 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-29-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-29-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-29-2020 15:35:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Roux-en-Y gastric
bypass
Start Date: Mar/20/2020
Ongoing: NO
End Date:
Mar/20/2020Initial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800292
Page 199 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:35:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:35:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Roux-en-Y gastric bypassInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-29-2020 15:35:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/20/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-29-2020 15:35:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/20/2020Initial Entry
1.f
Date Location User Value Reason
Jul-29-2020 15:36:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Fatty Liver Dise
ase
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800293
Page 200 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:36:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:36:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Fatty Liver DiseaseInitial Entry
1.f Start Date:
Date Location User Value Reason
Jul-29-2020 15:36:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jul-29-2020 15:36:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Jul-29-2020 15:37:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Vitamin B12 defic
iency
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800294
Page 201 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:37:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:37:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Vitamin B12 deficiencyInitial Entry
1.g Start Date:
Date Location User Value Reason
Jul-29-2020 15:37:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Jul-29-2020 15:37:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Jul-29-2020 15:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:vitamin D deficie
ncy
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800295
Page 202 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
vitamin D deficiencyInitial Entry
1.h Start Date:
Date Location User Value Reason
Jul-29-2020 15:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Jul-29-2020 15:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Jul-29-2020 15:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:nearsighted
Start Date: UNK/UNK/19
70
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800296
Page 203 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
nearsightedInitial Entry
1.i Start Date:
Date Location User Value Reason
Jul-29-2020 15:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.i Ongoing:
Date Location User Value Reason
Jul-29-2020 15:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Jul-29-2020 15:40:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:macular dystrophy
left eye
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800297
Page 204 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:40:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:40:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
macular dystrophy left eyeInitial Entry
1.j Start Date:
Date Location User Value Reason
Jul-29-2020 15:40:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Jul-29-2020 15:40:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Jul-29-2020 15:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:hole in Retina
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800298
Page 205 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hole in RetinaInitial Entry
1.k Start Date:
Date Location User Value Reason
Jul-29-2020 15:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.k Ongoing:
Date Location User Value Reason
Jul-29-2020 15:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Jul-29-2020 15:42:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:right Carpal tunnel s
yndrome
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800299
Page 206 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:42:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:42:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
right Carpal tunnel syndromeInitial Entry
1.l Start Date:
Date Location User Value Reason
Jul-29-2020 15:42:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Jul-29-2020 15:42:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Jul-29-2020 15:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Te
rm:Diabetic neuropa
thy
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800300
Page 207 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Diabetic neuropathyInitial Entry
1.m Start Date:
Date Location User Value Reason
Jul-29-2020 15:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.m Ongoing:
Date Location User Value Reason
Jul-29-2020 15:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Jul-29-2020 15:43:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History Ter
m:Sleep apnea
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800301
Page 208 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:43:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:43:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sleep apneaInitial Entry
1.n Start Date:
Date Location User Value Reason
Jul-29-2020 15:43:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Jul-29-2020 15:43:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Jul-29-2020 15:44:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:15
Medical History T
erm:dermatitis of the s
calp
Start Date: UNK/UNK/1980
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800302
Page 209 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:44:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:44:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
dermatitis of the scalpInitial Entry
1.o Start Date:
Date Location User Value Reason
Jul-29-2020 15:44:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.o Ongoing:
Date Location User Value Reason
Jul-29-2020 15:44:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Jul-29-2020 15:45:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Ter
m:Trigger finger
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800303
Page 210 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:45:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:45:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Trigger fingerInitial Entry
1.p Start Date:
Date Location User Value Reason
Jul-29-2020 15:45:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.p Ongoing:
Date Location User Value Reason
Jul-29-2020 15:45:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Jul-29-2020 15:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:17
Medical History T
erm:type ii diabetes m
ellitus
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800304
Page 211 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
type ii diabetes mellitusInitial Entry
1.q Start Date:
Date Location User Value Reason
Jul-29-2020 15:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.q Ongoing:
Date Location User Value Reason
Jul-29-2020 15:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Jul-29-2020 15:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Ter
m:High cholester
ol
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800305
Page 212 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.r Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
High cholesterolInitial Entry
1.r Start Date:
Date Location User Value Reason
Jul-29-2020 15:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.r Ongoing:
Date Location User Value Reason
Jul-29-2020 15:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Jul-29-2020 15:48:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History Ter
m:overweight
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800306
Page 213 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.s Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:48:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:48:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
overweightInitial Entry
1.s Start Date:
Date Location User Value Reason
Jul-29-2020 15:48:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.s Ongoing:
Date Location User Value Reason
Jul-29-2020 15:48:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Jul-29-2020 15:50:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:20
Medical History
Term:right bundle branc
h block
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800307
Page 214 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.t Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:50:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:50:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
right bundle branch blockInitial Entry
1.t Start Date:
Date Location User Value Reason
Jul-29-2020 15:50:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.t Ongoing:
Date Location User Value Reason
Jul-29-2020 15:50:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Jul-29-2020 15:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 21
Medical History Ter
m:ST depression
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800308
Page 215 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291005 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.u Line/MH Number:
Date Location User Value Reason
Jul-29-2020 15:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 15:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ST depressionInitial Entry
1.u Start Date:
Date Location User Value Reason
Jul-29-2020 15:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.u Ongoing:
Date Location User Value Reason
Jul-29-2020 15:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Jul-29-2020 15:53:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 22
Medical History Ter
m:anxiety
Start Date: Jan/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae30ae\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800309
Page 216 of 357
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
…[truncated]