Document text
Page 1 of 128
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925275
Page 2 of 128
***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: 11101220 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
Sep/4/2020
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925276
Page 3 of 128
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11101220]
2.Birth Date: /1971
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925277
Page 4 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925278
Page 5 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925279
Page 6 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925280
Page 7 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925281
Page 8 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [86.18]
3.Unit: kg
4.Height: [167.64]
5.Unit: cm
6.Body Mass Index: [30.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925282
Page 9 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [82241]
3.Randomization Group: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925283
Page 10 of 128
***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: 11101220 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:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY0P1]
5.bSample ID [BRWP9Z]
5.cSample ID [BRWPB0]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925284
Page 11 of 128
***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: 11101220 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:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY0TS]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925285
Page 12 of 128
***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: 11101220 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: Sep/4/2020 15:59
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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925286
Page 13 of 128
***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: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925287
Page 14 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925288
Page 15 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925289
Page 16 of 128
***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: 11101220 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:
Sep/24/2020
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 [BPY0G2]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925290
Page 17 of 128
***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: 11101220 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: Sep/24/2020 15:17
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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925291
Page 18 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925292
Page 19 of 128
***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: 11101220 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVHV6]
5.bSample ID [BRVHV5]
5.cSample ID [BPW5D6]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925293
Page 20 of 128
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925294
Page 21 of 128
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: 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: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925295
Page 22 of 128
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925296
Page 23 of 128
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925297
Page 24 of 128
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925298
Page 25 of 128
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925299
Page 26 of 128
***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: 11101220 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:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925300
Page 27 of 128
***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: 11101220 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: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925301
Page 28 of 128
***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: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925302
Page 29 of 128
***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: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925303
Page 30 of 128
***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: 11101220 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?
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925304
Page 31 of 128
***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: 11101220 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:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925305
Page 32 of 128
***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: 11101220 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:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925306
Page 33 of 128
***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: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925307
Page 34 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925308
Page 35 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: UNPLANNED VISIT
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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925309
Page 36 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/28/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER
PRESENT
3.Comments: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925310
Page 37 of 128
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925311
Page 38 of 128
***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: 11101220 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: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925312
Page 39 of 128
***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: 11101220 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:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925313
Page 40 of 128
***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: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925314
Page 41 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Bilateral axillar
y adenopathy Sep/25/2020
UNK:UNK NO
End Date Time:
Sep/27/2020 UN
K:UNK
Repeating
Pages
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925315
Page 42 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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)[Bilateral axillary adenopathy]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/27/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925316
Page 43 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925317
Page 44 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925318
Page 45 of 128
***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: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925319
Page 46 of 128
***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: 11101220 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[ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925320
Page 47 of 128
***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: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925321
Page 48 of 128
***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: 11101220 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: //
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925322
Page 49 of 128
***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: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925323
Page 50 of 128
***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: 11101220 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?
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925324
Page 51 of 128
***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: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925325
Page 52 of 128
***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: 11101220 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?
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925326
Page 53 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925327
Page 54 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925328
Page 55 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925329
Page 56 of 128
***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: 11101220 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:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925330
Page 57 of 128
***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: 11101220 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?
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925331
Page 58 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925332
Page 59 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925333
Page 60 of 128
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925334
Page 61 of 128
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925335
Page 62 of 128
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925336
Page 63 of 128
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925337
Page 64 of 128
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925338
Page 65 of 128
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925339
Page 66 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925340
Page 67 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925341
Page 68 of 128
***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: 11101220 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: [ ]
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925342
Page 69 of 128
***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: 11101220 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 Oct/28/2020
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925343
Page 70 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925344
Page 71 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
Name Signature
MeaningDate Type Action
Jeffrey
Rosen Approved Jan-25-2021 19:36:07 (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.
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925345
Page 72 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-04-2020 19:56:38
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925346
Page 73 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-04-2020 19:57:10
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925347
Page 74 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
Name Signature
MeaningDate Type Action
Jeffrey
Rosen Approved Jan-25-2021 19:36:07 (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 Jan-22-2021 12:42:52 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Jan-21-2021 10:56:00 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925348
Page 75 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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 Dec-18-2020 10:47:28 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Nov-03-2020 16:55:55 (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.
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925349
Page 76 of 128
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
Sep-04-2020
19:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020
19:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925350
Page 77 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/4/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925351
Page 78 of 128
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020
19:55:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11101220Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020
19:55:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1971Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020
19:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925352
Page 79 of 128
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
19:56:11
(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
Sep-04-2020
19:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925353
Page 80 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
19:56:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925354
Page 81 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
Sep-04-2020
19:56:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020
19:56:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020
19:56:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925355
Page 82 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
86.18Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925356
Page 83 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
167.64Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.7Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020
19:58:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925357
Page 84 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Temperatu
re Unit:C
Temperatu
re Locatio
n::FORE
HEA
D
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature:
Temperature U
nit:
Temperature Lo
cation::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
19:57:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020
19:58:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925358
Page 85 of 128
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a Unit:
Date Location User Value Reason
Sep-04-2020
19:58:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
19:58:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925359
Page 86 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020
19:58:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020
19:58:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
82241Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925360
Page 87 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
21:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
21:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
21:07:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
21:06:00
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925361
Page 88 of 128
***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: 11101220 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.
Sep-04-2020
21:06:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
21:07:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY0P
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
21:07:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY0P1Initial Entry
5.b
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925362
Page 89 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-04-2020
21:08:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRWP9
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020
21:08:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRWP9ZInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
21:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRWP
B0Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925363
Page 90 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Sep-04-2020
21:08:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRWPB0Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925364
Page 91 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
21:05:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
21:05:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
21:05:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
21:05:25
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925365
Page 92 of 128
***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: 11101220 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.
Sep-04-2020
21:05:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
21:05:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY0T
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
21:05:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY0TSInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925366
Page 93 of 128
***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: 11101220 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
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925367
Page 94 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 15:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925368
Page 95 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
19:59:21
(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
Sep-04-2020
19:59:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925369
Page 96 of 128
***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: 11101220 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
Sep-04-2020
19:59:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925370
Page 97 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020
19:34:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925371
Page 98 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.2
Temperatu
re Unit:C
Temperatu
re Locatio
n::FORE
HEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925372
Page 99 of 128
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020
19:34:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925373
Page 100 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020
19:35:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
19:35:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
19:36:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
19:35:46
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925374
Page 101 of 128
***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: 11101220 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.
Sep-24-2020
19:35:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
19:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY0G
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
19:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY0G2Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925375
Page 102 of 128
***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: 11101220 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
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925376
Page 103 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020 15:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925377
Page 104 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020
19:35:24
(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
Sep-24-2020
19:35:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925378
Page 105 of 128
***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: 11101220 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-28-2020
18:28:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925379
Page 106 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
18:29:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
18:29:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
18:29:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
18:29:09
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925380
Page 107 of 128
***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: 11101220 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-28-2020
18:29:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
18:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVH
V6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
18:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVHV6Initial Entry
5.b
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925381
Page 108 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-28-2020
18:29:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVH
V5Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020
18:29:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVHV5Initial Entry
5.c
Date Location User Value Reason
Oct-28-2020
18:29:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPW5
D6Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925382
Page 109 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Oct-28-2020
18:29:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW5D6Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925383
Page 110 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020
16:40:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925384
Page 111 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: UNPLANNED VISIT - 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Assessments
Date Location User Value Reason
Sep-28-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
16:40:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Sep-28-2020
16:40:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTC
OMEInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925385
Page 112 of 128
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Sep/28/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-28-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-28-2020
16:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Sep/28/2020
Contact Outcome:
VISIT NOT AR
RANGED, REA
CTION NO LON
GER PRESENTInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925386
Page 113 of 128
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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-28-2020
18:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020
18:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020
18:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925387
Page 114 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925388
Page 115 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-29-2020
21:21:49
(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
Oct-21-2020
20:46:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-20-2020
18:52:28
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answere
dTranscription
Error
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925389
Page 116 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US & Canada)
Oct-20-2020
18:52:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral axillary
adenopathyTranscription
Error
Oct-20-2020
01:30:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery:
axillary
adenopathy:
please Specify
whether
bilateral, left or
right
Oct-19-2020
20:48:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Candidat
eClinQuery:
axillary
adenopathy:
please Specify
whether
bilateral, left or
right
Oct-11-2020
20:30:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-06-2020
14:31:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
axillary adenopath
yTranscription
Error
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925390
Page 117 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-06-2020
10:48:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dAxillary
Adenopathy
Oct-06-2020
02:35:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Adenopathy
axillar: Please
confirm
spelling of AE
term.
Oct-05-2020
21:42:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidat
eClinQuery:
Adenopathy
axillar: Please
confirm
spelling of AE
term.
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
adenopathy axillarInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 UNK:
UNKInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925391
Page 118 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/27/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925392
Page 119 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
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
Sep-29-2020
21:21:49
(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
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925393
Page 120 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-29-2020
21:21:49
(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
Sep-29-2020
21:24:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-29-2020
21:24:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/R
ESOLVEDTranscription
Error
Sep-29-2020
21:21:49ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
adenopathy
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925394
Page 121 of 128
***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, Locked, Frozen
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time
(US & Canada)axillar:
Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End Date/Time
is provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-29-2020
21:21:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925395
Page 122 of 128
***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, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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-18-2020
10:47:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925396
Page 123 of 128
***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, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 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
Jan-30-2021
11:55:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-26-2021
17:17:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dupdated
Jan-25-2021
23:19:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Pls document
in source how
subject met
eligibility for
unblinding
Jan-22-2021
12:42:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at
Vaccination 1/2Transcription
Error
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925397
Page 124 of 128
***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, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-18-2020
10:47:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT
willing to return fo
r Vaccination 3 O
R otherwise not eli
gibleInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925398
Page 125 of 128
***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, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-18-2020
10:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-18-2020
10:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925399
Page 126 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-28-2020
18:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020
19:58:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-04-2020
19:56:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-28-2020
18:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/28/2020Initial Entry
Sep-04-2020
19:58:52ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925400
Page 127 of 128
***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: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-04-2020
19:56:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925401
Page 128 of 128
***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, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020
15:31:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3d94\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925402