125742 S1 M5 CRF c4591001 1110 11101367

Document text

Page 1 of 179
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926376
Page 2 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/21/2020
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926377
Page 3 of 179
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11101367]
2.Birth Date: /1958
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926378
Page 4 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926379
Page 5 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926380
Page 6 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926381
Page 7 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Diabetes Mellitus Type II]
Start Date: Jul/29/2011
Ongoing: YES
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926382
Page 8 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926383
Page 9 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
2.Weight: [82.1]
3.Unit: kg
4.Height: [166.1]
5.Unit: cm
6.Body Mass Index: [29.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926384
Page 10 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/21/2020
2.Randomization Number: [271964]
3.Randomization Group: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926385
Page 11 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSGW8Z]
5.bSample ID [BSGW8Y]
5.cSample ID [BPW9J9]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926386
Page 12 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW9CV]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926387
Page 13 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/21/2020 15:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926388
Page 14 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926389
Page 15 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926390
Page 16 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926391
Page 17 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/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 [BPW5GX]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926392
Page 18 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/19/2020 13:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926393
Page 19 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926394
Page 20 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BPW5JS]
5.bSample ID [BNPZ0Y]
5.cSample ID [BNPZ0X]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926395
Page 21 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926396
Page 22 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926397
Page 23 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926398
Page 24 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926399
Page 25 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
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?
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926400
Page 26 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926401
Page 27 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926402
Page 28 of 179
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926403
Page 29 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926404
Page 30 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926405
Page 31 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  uncontrolled bloo
d sugar (glucose) Nov/20/2020
UNK:UNK NO
End Date Time:
Nov/23/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  lower back pain  Nov/17/2020
UNK:UNK NO
End Date Time:
Jan/10/2021 UN
K:UNK
 Repeating
Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926406
Page 32 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[uncontrolled blood sugar (glucose)]
4.Start Date Time: Nov/20/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/23/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926407
Page 33 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[uncontrolled diabetes mellitus type 2]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926408
Page 34 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020500973]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926409
Page 35 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[lower back pain]
4.Start Date Time: Nov/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/10/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926410
Page 36 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926411
Page 37 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926412
Page 38 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926413
Page 39 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926414
Page 40 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926415
Page 41 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: //
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926416
Page 42 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926417
Page 43 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926418
Page 44 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926419
Page 45 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926420
Page 46 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926421
Page 47 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926422
Page 48 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926423
Page 49 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926424
Page 50 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926425
Page 51 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926426
Page 52 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926427
Page 53 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926428
Page 54 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926429
Page 55 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926430
Page 56 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/12/2021
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926431
Page 57 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BPLH50]
5.bSample ID [BPLH47]
5.cSample ID [BN4ZFF]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926432
Page 58 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BPZXD4]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926433
Page 59 of 179
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926434
Page 60 of 179
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BPZXJK]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926435
Page 61 of 179
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926436
Page 62 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926437
Page 63 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926438
Page 64 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926439
Page 65 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/26/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926440
Page 66 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926441
Page 67 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926442
Page 68 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926443
Page 69 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/12/2021
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926444
Page 70 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926445
Page 71 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926446
Page 72 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BR1684]
5.bSample ID [BRW8TM]
5.cSample ID [BRW8TN]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926447
Page 73 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BR16GZ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926448
Page 74 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/12/2021 10:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926449
Page 75 of 179
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926450
Page 76 of 179
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926451
Page 77 of 179
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926452
Page 78 of 179
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926453
Page 79 of 179
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926454
Page 80 of 179
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926455
Page 81 of 179
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926456
Page 82 of 179
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926457
Page 83 of 179
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926458
Page 84 of 179
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926459
Page 85 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/17/2020
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926460
Page 86 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926461
Page 87 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926462
Page 88 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-21-2020 17:10:43 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926463
Page 89 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormMar-12-2021 16:49:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926464
Page 90 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-12-2021 16:30:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Mar-11-2021 14:30:44 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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 Mar-10-2021 18:16:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926465
Page 91 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
N/A
Jeffrey
Rosen Approved Feb-25-2021 22:21:10 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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 Feb-23-2021 17:01:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Feb-18-2021 15:41:46 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926466
Page 92 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, JeffreyRosen, 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 Feb-12-2021 13:55:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Jan-21-2021 13:24:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926467
Page 93 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
 N/A Dec-17-2020 15:18:21 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Dec-10-2020 17:32:09 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926468
Page 94 of 179
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-21-2020
17:09:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-21-2020
17:09:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926469
Page 95 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020
17:09:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Oct/21/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926470
Page 96 of 179
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-31-2020
03:07:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
ClosedResponse satisfies query
Dec-22-2020
15:50:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Answere
ddone
Dec-18-2020
09:21:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
OpenedSAE
RECON:AER#2020500973
uncontrolled blood sugar
(glucose)(20Nov2020) was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Dec-18-2020
09:21:12
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Query 1:
Closedincorrect query text
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926471
Page 97 of 179
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Dec-18-2020
09:20:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020500973
psoriatic
arthritis(26Sep2020) was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-21-2020
17:08:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Ent
ry:
11101367Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020
17:08:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-21-2020
17:09:59
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926472
Page 98 of 179
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020
17:09:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020
17:09:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926473
Page 99 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020
17:10:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926474
Page 100 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020
17:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020
17:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020
17:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926475
Page 101 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020
17:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:Diabetes
Mellitus T
ype II
Start Dat
e:Jul/29/201
1
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020
17:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020
17:12:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Diabetes Mellitus T
ype IIInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926476
Page 102 of 179
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-21-2020
17:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020
17:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926477
Page 103 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020
17:12:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926478
Page 104 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
82.1Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926479
Page 105 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
166.1Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.8Initial Entry
7.a
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926480
Page 106 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Temperatu
re Unit:C
Temperatu
re Locatio
n::FORE
HEA
D
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926481
Page 107 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020
17:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926482
Page 108 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020
17:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020
17:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
271964Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926483
Page 109 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
17:14:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
17:14:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
17:15:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
17:14:48
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926484
Page 110 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-21-2020
17:14:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
17:15:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSGW8
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
17:15:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSGW8ZInitial Entry
5.b
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926485
Page 111 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-21-2020
17:15:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSGW8
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
17:15:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSGW8YInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020
17:15:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPW9J
9Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926486
Page 112 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
17:15:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPW9J9Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926487
Page 113 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
17:16:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
17:16:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
17:16:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
17:16:11
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926488
Page 114 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-21-2020
17:16:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
17:16:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPW9C
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
17:16:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPW9CVInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926489
Page 115 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926490
Page 116 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 15:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926491
Page 117 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-21-2020
17:16:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926492
Page 118 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-21-2020
17:17:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926493
Page 119 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020
01:29:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD
tracker
Nov-20-2020
08:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dVisit is OOW.
Subject did not
provided
explanation.
Protocol
deviation is in
subject's chart
Nov-20-2020
01:15:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at
this visit is out
of window (6
day) from
DOV (21/Oct
/2020) at
V1D1VX1L.
Please either
update DOV or
confirm
whether visit is
out of window
due to
temporary
delay of
vaccination/
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926494
Page 120 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
else provide
details as
appropriate.
Nov-19-2020
16:36:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926495
Page 121 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:36.4
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926496
Page 122 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.a Temperature:
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-19-2020
16:38:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926497
Page 123 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020
16:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020
16:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020
16:40:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-19-2020
16:39:00
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926498
Page 124 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-19-2020
16:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020
16:42:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPW5G
XTranscription
Error
Nov-19-2020
16:40:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:1110-13
67Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020
16:42:30
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926499
Page 125 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
Nov-19-2020
16:42:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPW5GXTranscription
Error
Nov-19-2020
16:40:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Nov-19-2020
16:40:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1110-1367Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926500
Page 126 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926501
Page 127 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020 13:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926502
Page 128 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-19-2020
16:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926503
Page 129 of 179
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020
15:18:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926504
Page 130 of 179
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
15:18:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
15:18:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
15:21:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
15:18:53
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926505
Page 131 of 179
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-17-2020
15:18:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020
15:21:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPW5J
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020
15:21:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPW5JSInitial Entry
5.b
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926506
Page 132 of 179
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-17-2020
15:23:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNPZ0
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020
15:23:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNPZ0YInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020
15:23:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNPZ0
XInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020
15:23:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNPZ0XInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926507
Page 133 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926508
Page 134 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926509
Page 135 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-06-2021
10:13:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Thank you!
Dec-28-2020
19:31:45
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answere
dcorrect value is
380. a follow
up report was
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0926510
Page 136 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US & Canada)sent
Dec-23-2020
16:11:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per
report, the
subject had
"uncontrolled
blood sugar
levels
(glucose) at
3380." Kindly
revise value
and provide
correct units
used.
Additionally,
please provide
further work up
performed
during hospital
stay in a FU
form. Thank
you.
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
uncontrolled blood
sugar (glucose)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-22-2020 ACV0PFEINFP6000  Data Entry: Transcription
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926511
Page 137 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
15:29:37
(UTC-05:00)
Eastern Time
(US & Canada)Nov/20/2020 UN
K:UNKError
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/20/2020 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-22-2020
15:29:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For
uncontrolled
blood sugar
(glucose) End
Date & Time
23/Nov/2020
UNK:UNK is
before the Start
Date & Time
20/Dec/2020
UNK:UNK.
Dec-22-2020
15:29:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926512
Page 138 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada) Nov/23/2020 U
NK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
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).
Date Location User Value Reason
Dec-31-2020
03:06:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE
uncontrolled
blood sugar
(glucose):
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926513
Page 139 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada) Response to
"Is the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wit
h congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or pr
olong hospitaliza
tion?
YES
Did this serious e
vent result in per
sistent or significInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926514
Page 140 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ant disability/inc
apacity?
NO
Is this serious ev
ent life threatenin
g?
NO
Other medically i
mportant serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926515
Page 141 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
uncontrolled d
iabetes mellitu
s type 2
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926516
Page 142 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-22-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-31-2020
03:06:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020500973Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0926517
Page 143 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
lower back painInitial Entry
4. Start Date Time:
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926518
Page 144 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/17/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021
22:15:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-10-2021
18:16:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Mar-10-2021
18:16:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/10/2021 U
NK:UNKTranscription
Error
Mar-10-2021
16:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened per source end
date is
10Jan21. Pls
update
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926519
Page 145 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926520
Page 146 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926521
Page 147 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021
22:14:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-10-2021
18:17:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926522
Page 148 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Mar-10-2021
18:17:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redTranscription
Error
Mar-10-2021
18:17:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/
RESOLVEDTranscription
Error
Mar-10-2021
18:16:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dFor AE lower
back pain:
Response to
"What was the
outcome of this
adverse event?" is
'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Mar-10-2021
16:49:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dpls update
outcome per
source to
recovered/resolved
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926523
Page 149 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-22-2020
15:32:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926524
Page 150 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021
13:55:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926525
Page 151 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021
13:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/12/2021Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926526
Page 152 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021
13:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021
13:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021
13:56:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-12-2021
13:56:00
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926527
Page 153 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-12-2021
13:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021
13:56:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLH50Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-12-2021
13:56:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLH50Initial Entry
5.b
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926528
FDA-CBER-2021-5683-0926529
Page 155 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021
13:59:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021
13:59:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021
14:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-12-2021
13:59:27
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926530
Page 156 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-12-2021
13:59:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021
14:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPZXD
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-12-2021
14:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPZXD4Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926531
Page 157 of 179
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
17:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-23-2021
17:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926532
Page 158 of 179
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021
17:01:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021
17:01:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021
17:02:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-23-2021
17:01:54
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926533
Page 159 of 179
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-23-2021
17:01:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021
17:02:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPZXJ
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-23-2021
17:02:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPZXJKInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926534
Page 160 of 179
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-17-2020
15:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020
15:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020
15:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926535
Page 161 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
16:32:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-12-2021
16:32:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Transcription
Error
Mar-12-2021
16:30:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Visit,
26/Mar/2021 is
a future date
relative to
when it was
entered on
12/Mar/2021.
Please correct.
Mar-12-2021
16:30:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/26/2021Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926536
Page 162 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-12-2021
16:35:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
16:31:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Mar-12-2021
16:31:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed toInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926537
Page 163 of 179
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
have received o
nly placebo at
Vaccination 1/2
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926538
Page 164 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-12-2021
16:43:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Transcription
Error
Mar-12-2021
16:35:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-12-2021
16:35:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926539
Page 165 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
16:48:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926540
Page 166 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-12-2021
16:48:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Mar/12/2021Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926541
Page 167 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-12-2021
16:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021
16:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021
16:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926542
Page 168 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
16:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
16:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
16:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926543
Page 169 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Mar-12-2021
16:51:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR168
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
16:51:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR1684Initial Entry
5.b
Date Location User Value Reason
Mar-12-2021
16:53:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRW8T
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
16:53:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRW8TMInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926544
Page 170 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c
Date Location User Value Reason
Mar-12-2021
16:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRW8T
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
16:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRW8TNInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926545
Page 171 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
16:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
16:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
16:54:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
16:54:31
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926546
Page 172 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
16:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
16:54:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR16G
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
16:54:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR16GZInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926547
Page 173 of 179
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926548
Page 174 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/12/2021 10:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926549
Page 175 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
8. Actual Dose:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-12-2021
16:56:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Mar-12-2021
16:56:50ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926550
Page 176 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926551
Page 177 of 179
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-17-2020
15:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-21-2020
17:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-21-2020
17:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-17-2020
15:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/17/2020Initial Entry
Oct-21-2020
17:14:23ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926552
Page 178 of 179
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-21-2020
17:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926553
Page 179 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101367 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
19:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3da2\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926554