Document text
Page 1 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924621
Page 2 of 150
***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: 11101164 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
Aug/29/2020
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924622
Page 3 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11101164]
2.Birth Date: /1986
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924623
Page 4 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924624
Page 5 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924625
Page 6 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924626
Page 7 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924627
Page 8 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
2.Weight: [165.8]
3.Unit: LB
4.Height: [70.8]
5.Unit: in
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924628
Page 9 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/29/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924629
Page 10 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/29/2020
2.Randomization Number: [73633]
3.Randomization Group: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924630
Page 11 of 150
***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: 11101164 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:
Aug/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3HKF]
5.bSample ID [BP3HKG]
5.cSample ID [BP3HKH]
5.dSample ID [BRWP6C]
5.eSample ID [BRWP6D]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924631
Page 12 of 150
***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: 11101164 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:
Aug/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY0LJ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924632
Page 13 of 150
***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: 11101164 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: Aug/29/2020 12:16
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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924633
Page 14 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924634
Page 15 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924635
Page 16 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924636
Page 17 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924637
Page 18 of 150
***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: 11101164 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/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY06N]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924638
Page 19 of 150
***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: 11101164 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/18/2020 09:59
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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924639
Page 20 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924640
Page 21 of 150
***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: 11101164 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/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW9H4]
5.bSample ID [BSGW6M]
5.cSample ID [BSGW6L]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924641
Page 22 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924642
Page 23 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924643
Page 24 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924644
Page 25 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924645
Page 26 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924646
Page 27 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924647
Page 28 of 150
***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: 11101164 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:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924648
Page 29 of 150
***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: 11101164 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: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924649
Page 30 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924650
Page 31 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924651
Page 32 of 150
***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: 11101164 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?
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924652
Page 33 of 150
***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: 11101164 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:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924653
Page 34 of 150
***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: 11101164 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:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924654
Page 35 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924655
Page 36 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924656
Page 37 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924657
Page 38 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 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:
Oct/12/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN
E-DIARY
3.Comments: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924658
Page 39 of 150
***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: 11101164 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/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924659
Page 40 of 150
***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: 11101164 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: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924660
Page 41 of 150
***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: 11101164 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:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924661
Page 42 of 150
***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: 11101164 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 [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924662
Page 43 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924663
Page 44 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924664
Page 45 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924665
Page 46 of 150
***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: 11101164 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[ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924666
Page 47 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924667
Page 48 of 150
***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: 11101164 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: //
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924668
Page 49 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924669
Page 50 of 150
***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: 11101164 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?
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924670
Page 51 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924671
Page 52 of 150
***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: 11101164 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?
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924672
Page 53 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924673
Page 54 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924674
Page 55 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924675
Page 56 of 150
***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: 11101164 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:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924676
Page 57 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924677
Page 58 of 150
***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: 11101164 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?
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924678
Page 59 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924679
Page 60 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924680
Page 61 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924681
Page 62 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/19/2021
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924682
Page 63 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZX83]
5.bSample ID [BSGVMZ]
5.cSample ID [BSGVN0]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924683
Page 64 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZXGM]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924684
Page 65 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/01/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924685
Page 66 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR16B8]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924686
Page 67 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/11/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924687
Page 68 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR16GF]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924688
Page 69 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924689
Page 70 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924690
Page 71 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924691
Page 72 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924692
Page 73 of 150
***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: 11101164 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: [ ]
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924693
Page 74 of 150
***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: 11101164 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/19/2020
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924694
Page 75 of 150
***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: 11101164 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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924695
Page 76 of 150
***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: 11101164 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 Mar-12-2021 11:37:59 (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.
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924696
Page 77 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-29-2020 15:42:18
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924697
Page 78 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-29-2020 15:43:05
(UTC-05:00) Eastern Time (US &
Canada)Healthy
Not Applicable
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924698
Page 79 of 150
***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: 11101164 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 Mar-12-2021 11:37:59 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-11-2021 11:48:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Mar-02-2021 18:51:39 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924699
Page 80 of 150
***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: 11101164 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 Mar-01-2021 13:56:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Feb-23-2021 18:57:07 (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.
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924700
Page 81 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
N/A Feb-19-2021 09:14:45 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Jan-25-2021 19:28:55 (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.
N/A Jan-22-2021 12:37:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Jan-21-2021 10:46:03 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924701
Page 82 of 150
***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: 11101164 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 Jan-08-2021 11:18:50 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey
Rosen Approved Oct-26-2020 11:26:15 (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.
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924702
Page 83 of 150
***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: 11101164 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
Aug-29-2020
15:41:13
(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
Aug-29-2020
15:41:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHO
RTSInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924703
Page 84 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020
15:41:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Aug/29/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924704
Page 85 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020
15:41:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11101164Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020
15:40:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1986Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020
15:41:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924705
Page 86 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-29-2020
15:41:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC
OR LATINO(A)
OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020
15:41:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924706
Page 87 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-29-2020
15:42:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924707
Page 88 of 150
***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: 11101164 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
Aug-29-2020
15:42:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020
15:42:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020
15:42:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924708
Page 89 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
165.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924709
Page 90 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
70.8Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3Initial Entry
7.a
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record I
dentifier:
:1Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924710
Page 91 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Temperat
ure:36.5
Temperat
ure Unit:C
Temperat
ure Locat
ion::FOR
EHE
AD
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924711
Page 92 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US & Canada)
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020
15:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924712
Page 93 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924713
Page 94 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924714
Page 95 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotro
pin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-29-2020
15:44:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924715
Page 96 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020
15:45:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020
15:45:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
73633Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924716
Page 97 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020
21:35:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020
21:35:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020
21:36:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-29-2020
21:35:00
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924717
Page 98 of 150
***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: 11101164 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.
Aug-29-2020
21:35:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020
21:36:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3HK
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-29-2020
21:36:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3HKFInitial Entry
5.b
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924718
Page 99 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-29-2020
21:36:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3HK
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020
21:36:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3HKGInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020
21:36:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3HK
HInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924719
Page 100 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Aug-29-2020
21:36:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3HKHInitial Entry
5.d
Date Location User Value Reason
Aug-29-2020
21:37:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRWP6
CInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-29-2020
21:37:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRWP6CInitial Entry
5.e
Date Location User Value Reason
Aug-29-2020
21:37:29ACV0PFEINFP6000 Data Entry:
Sample I BRWP6Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924720
Page 101 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)D: D
5.e Sample ID
Date Location User Value Reason
Aug-29-2020
21:37:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRWP6DInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924721
Page 102 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020
21:34:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020
21:34:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020
21:34:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-29-2020
21:34:06
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924722
Page 103 of 150
***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: 11101164 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.
Aug-29-2020
21:34:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020
21:34:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY0L
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-29-2020
21:34:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY0LJInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924723
Page 104 of 150
***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: 11101164 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
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924724
Page 105 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/29/2020 12:
16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924725
Page 106 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-29-2020
15:45:25
(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
Aug-29-2020
15:45:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924726
Page 107 of 150
***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: 11101164 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
08:04:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1: C
losedResponse satisfies
query
Sep-03-2020
15:48:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredChanged Information
Sep-03-2020
15:48:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
NO - REA
CTOGENI
CITY E-D
IARY NO
T COLLE
CTED FO
R THIS S
UBJECTChanged Information
Sep-03-2020
02:52:40
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 1:
OpenedeDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924727
Page 108 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US &
Canada)THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-29-2020
15:45:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
YES - RE
ACTOGE
NICITY E
-DIARY C
OLLECTE
D FOR T
HIS SUBJ
ECTInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924728
Page 109 of 150
***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: 11101164 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-17-2020
06:11:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-16-2020
15:48:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edUpdated
Oct-15-2020
12:20:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness ediary:
As per Illness
ediary records,
subject
reported "Yes"
for the question
"Have you
experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
10OCT2020.
But
corresponding
COVID Illness
visit not
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924729
Page 110 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
reported. Please
clarify.
Sep-18-2020
14:21:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924730
Page 111 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
14:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
14:23:52
(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-18-2020
14:23:52
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924731
Page 112 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
14:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
14:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
14:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924732
Page 113 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924733
Page 114 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924734
Page 115 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
14:23:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924735
Page 116 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
19:56:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
19:56:30
(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-18-2020
19:56:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
19:56:30
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924736
Page 117 of 150
***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: 11101164 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-18-2020
19:56:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
19:56:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY06
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
19:56:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY06NInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924737
Page 118 of 150
***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: 11101164 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-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924738
Page 119 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 09:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
14:24:25
(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-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924739
Page 120 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
14:24:25
(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-18-2020
14:24:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924740
Page 121 of 150
***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: 11101164 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-19-2020
18:15:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924741
Page 122 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
18:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
18:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
18:53:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
18:53:05
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924742
Page 123 of 150
***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: 11101164 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-19-2020
18:53:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
18:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPW9
H4Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
18:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW9H4Initial Entry
5.b
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924743
Page 124 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-19-2020
18:53:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSGW6
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
18:53:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGW6MInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
18:53:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSGW6
LInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924744
Page 125 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
18:53:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGW6LInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924745
Page 126 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 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-16-2020
15:46:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924746
Page 127 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Assessments
Date Location User Value Reason
Oct-16-2020
15:47:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
15:46:10
(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.
Oct-16-2020
15:46:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTC
OMEInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924747
Page 128 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-16-2020
15:46:27
(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
Oct-16-2020
15:47:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-16-2020
15:47:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Oct/12/2020
Contact Outcom
e:
VISIT NOT RE
QUIRED, DAT
A ENTRY ER
ROR IN E-DIATranscription
Error
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924748
Page 129 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
RY
Oct-16-2020
15:46:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Date of
Contact" is
missing.
Oct-16-2020
15:46:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Contact Outcom
e:
VISIT NOT RE
QUIRED, DAT
A ENTRY ER
ROR IN E-DIA
RYInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924749
Page 130 of 150
***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: 11101164 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-19-2020
18:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
18:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
18:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924750
Page 131 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021
09:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924751
Page 132 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-19-2021
09:15:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/19/2021Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924752
Page 133 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021
14:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021
14:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
14:09:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
14:09:05
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924753
Page 134 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-19-2021
14:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/19/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
14:09:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPZX83Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021
14:09:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPZX83Initial Entry
5.b
Date Location User Value Reason
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924754
Page 135 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-19-2021
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSGVM
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-19-2021
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGVMZInitial Entry
5.c
Date Location User Value Reason
Feb-19-2021
14:10:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSGVN
0Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-19-2021
14:10:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGVN0Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924755
Page 136 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021
14:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021
14:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
14:11:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
14:11:11
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924756
Page 137 of 150
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-19-2021
14:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/19/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
14:11:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPZXG
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021
14:11:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPZXGMInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924757
Page 138 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/01/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
13:56:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-01-2021
13:56:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924758
Page 139 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
13:57:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
13:57:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
13:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-01-2021
13:57:03
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924759
Page 140 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
13:57:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
13:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR16B8Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
13:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR16B8Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924760
Page 141 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/11/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021
11:48:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/11/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-11-2021
11:48:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SSWAB_WEEK4Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924761
Page 142 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021
11:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-11-2021
11:49:02
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924762
Page 143 of 150
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-11-2021
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021
11:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR16G
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021
11:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR16GFInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924763
Page 144 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021
11:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924764
Page 145 of 150
***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: 11101164 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
11:54:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-27-2021
15:11:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dupdated, will
be upload to
Florence
Jan-25-2021
22:52:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Pls document
in source how
subject met
eligibility for
unblinding
Jan-22-2021
12:37:56
(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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924765
Page 146 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-08-2021
11:19:00
(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
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924766
Page 147 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-08-2021
11:19:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-08-2021
11:19:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924767
Page 148 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020
18:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-29-2020
15:45:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-29-2020
15:42:38
(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-19-2020
18:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-29-2020
15:45:05ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924768
Page 149 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-29-2020
15:42:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924769
Page 150 of 150
***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: 11101164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-15-2020
11:50:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3d9d\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924770