Document text
Page 1 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917305
Page 2 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917306
Page 3 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10571065]
2.Birth Date: /1975
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917307
Page 4 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917308
Page 5 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917309
Page 6 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917310
Page 7 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OBESITY]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TYPE II DIABETES MELLITUS]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917311
Page 8 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [100.4]
3.Unit: kg
4.Height: [168.5]
5.Unit: cm
6.Body Mass Index: [35.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917312
Page 9 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [58406]
3.Randomization Group: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917313
Page 10 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1GTW]
5.bSample ID [BP1GTX]
5.cSample ID [BP1GTY]
5.dSample ID [BPJ0LK]
5.eSample ID [BPJ0LL]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917314
Page 11 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1G9S]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917315
Page 12 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/21/2020 13:58
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
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917316
Page 13 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917317
Page 14 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917318
Page 15 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917319
Page 16 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP1GGS]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917320
Page 17 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/9/2020 14:38
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
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917321
Page 18 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917322
Page 19 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BKJYG3]
5.bSample ID [BKJYG4]
5.cSample ID [BKJYG5]
5.dSample ID [BPJ144]
5.eSample ID [BPJ145]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917323
Page 20 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917324
Page 21 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BRNRTN]
5.bSample ID [BRNRTP]
5.cSample ID [BRNRTR]
5.dSample ID [BS20PL]
5.eSample ID [BS20PM]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917325
Page 22 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917326
Page 23 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917327
Page 24 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917328
Page 25 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917329
Page 26 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917330
Page 27 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917331
Page 28 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917332
Page 29 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917333
Page 30 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917334
Page 31 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917335
Page 32 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917336
Page 33 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917337
Page 34 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917338
Page 35 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917339
Page 36 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917340
Page 37 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917341
Page 38 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917342
Page 39 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917343
Page 40 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 ACUTE CHOLECYS
TITIS Feb/5/202
1 10:10 NO
End Date Time:
Feb/8/2021 14:3
2
Repeating
Pages
2.ADVERS
E EVENT 2 POST CHOLECYST
ECTOMY ABSCESS
Feb/12/20
21 21:00 YES Repeating
Pages
3.ADVERS
E EVENT 3 STEATOHEPATITIS Feb/7/202
1 13:51 YES Repeating
Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917344
Page 41 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ACUTE CHOLECYSTITIS]
4.Start Date Time: Feb/5/2021 10:10
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/8/2021 14:32
6.Toxicity Grade: 3
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917345
Page 42 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[OBESE,DIABETES,BILE DUCT]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917346
Page 43 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021236691]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917347
Page 44 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[POST CHOLECYSTECTOMY ABSCESS]
4.Start Date Time: Feb/12/2021 21:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917348
Page 45 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
Did this serious event result in death?
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
Is this serious event life threatening?
Other medically important serious event
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CHOLECYSTECTOMY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917349
Page 46 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021241699]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917350
Page 47 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[STEATOHEPATITIS]
4.Start Date Time: Feb/7/2021 13:51
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917351
Page 48 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[DIET, OBESITY, METABOLIC]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917352
Page 49 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917353
Page 50 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917354
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917355
Page 52 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917356
Page 53 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917357
Page 54 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917358
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917359
Page 56 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917360
Page 57 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917361
Page 58 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917362
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917363
Page 60 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917364
Page 61 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917365
Page 62 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917366
Page 63 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917367
Page 64 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917368
Page 65 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917369
Page 66 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917370
Page 67 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917371
Page 68 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917372
Page 69 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917373
Page 70 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917374
Page 71 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917375
Page 72 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917376
Page 73 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917377
Page 74 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917378
Page 75 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917379
Page 76 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917380
Page 77 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-21-2020 13:49:24
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917381
Page 78 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-08-2021 04:29:25 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi
Chalhoub Approved Mar-05-2021 10:54:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, 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-05-2021 10:50:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917382
Page 79 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
N/A
Fadi
Chalhoub Approved Mar-05-2021 10:50:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, 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-05-2021 10:50:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi
Chalhoub Approved Mar-05-2021 10:45:59 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917383
Page 80 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, FadiChalhoub, 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-05-2021 10:45:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi
Chalhoub Approved Mar-04-2021 13:19:00 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, 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.
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917384
Page 81 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
N/A Mar-04-2021 11:05:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi
Chalhoub Approved Mar-04-2021 10:21:14 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-08-2021 13:23:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi
Chalhoub Approved Oct-23-2020 08:00:57 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917385
Page 82 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, FadiChalhoub, 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.
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917386
Page 83 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020
13:44:03
(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-21-2020
13:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917387
Page 84 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020
13:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/21/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917388
Page 85 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-21-2020
13:43:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10571065Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020
13:43:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1975Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020
13:44:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917389
Page 86 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-21-2020
13:44:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020
13:44:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917390
Page 87 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020
13:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917391
Page 88 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917392
Page 89 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020
13:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:OBESIT
Y
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020
13:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020
13:51:25
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
OBESITYInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917393
Page 90 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-21-2020
13:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020
13:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-21-2020
13:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:TYPE II DI
ABETES M
ELLITUS
Start Da
te:UNK/UNK/
2000Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917394
Page 91 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing
:YES
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917395
Page 92 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020
13:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020
13:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TYPE II DIABETE
S MELLITUSInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020
13:51:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020
13:51:41ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917396
Page 93 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917397
Page 94 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
100.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917398
Page 95 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
168.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.4Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:36.6Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917399
Page 96 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917400
Page 97 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020
13:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917401
Page 98 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020
13:52:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020
13:52:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
58406Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917402
Page 99 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
15:01:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
15:01:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
15:01:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
15:01:13
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917403
Page 100 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-21-2020
15:01:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
15:01:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP1GT
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP1GTWInitial Entry
5.b
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917404
Page 101 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-21-2020
15:01:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP1GT
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP1GTXInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020
15:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP1GT
YInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917405
Page 102 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP1GTYInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020
15:01:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPJ0L
KInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPJ0LKInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020
15:01:53ACV0PFEINFP6000 Data Entry:
Sample I BPJ0LInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917406
Page 103 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)D: L
5.e Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPJ0LLInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917407
Page 104 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
15:00:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
15:00:57
(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-21-2020
15:01:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
15:00:57
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917408
Page 105 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-21-2020
15:00:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
15:01:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP1G9
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
15:01:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP1G9SInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917409
Page 106 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917410
Page 107 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020 13:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020
13:58:29
(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-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917411
Page 108 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020
13:58:29
(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-21-2020
13:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917412
Page 109 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-21-2020
13:53:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917413
Page 110 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
02:44:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Not COVID
ILLNESS
Oct-06-2020
15:29:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dDid not meet
criteria for
ILLNESS
visit.
Oct-03-2020
10:57:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 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
17SEP2020.
But there is no
COVID Illness
visit reported
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917414
Page 111 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
in the
database.
Sep-10-2020
12:37:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917415
Page 112 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917416
Page 113 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
12:37:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917417
Page 114 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
18:01:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
18:01:16
(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-10-2020
18:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
18:01:16
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917418
Page 115 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-10-2020
18:01:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
18:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP1GG
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
18:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP1GGSInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917419
Page 116 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917420
Page 117 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 14:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
12:38:08
(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-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917421
Page 118 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
12:38:08
(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-10-2020
12:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917422
Page 119 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
13:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917423
Page 120 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
16:53:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
16:53:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:53:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
16:53:29
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917424
Page 121 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
16:53:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:53:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BKJYG
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:53:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BKJYG3Initial Entry
5.b
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917425
Page 122 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-07-2020
16:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BKJYG
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020
16:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BKJYG4Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020
16:53:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BKJYG
5Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917426
Page 123 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Oct-07-2020
16:53:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BKJYG5Initial Entry
5.d
Date Location User Value Reason
Oct-07-2020
16:54:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPJ14
4Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-07-2020
16:54:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPJ144Initial Entry
5.e
Date Location User Value Reason
Oct-07-2020
16:54:17ACV0PFEINFP6000 Data Entry:
Sample ID BPJ14Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917427
Page 124 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada): 5
5.e Sample ID
Date Location User Value Reason
Oct-07-2020
16:54:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPJ145Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917428
Page 125 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
11:05:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917429
Page 126 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021
11:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021
11:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-04-2021
11:05:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-04-2021
11:05:22
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917430
Page 127 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-04-2021
11:05:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021
11:05:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRNRT
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
11:05:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNRTNInitial Entry
5.b
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917431
Page 128 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-04-2021
11:05:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRNRT
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-04-2021
11:05:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNRTPInitial Entry
5.c
Date Location User Value Reason
Mar-04-2021
11:05:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRNRT
RInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917432
Page 129 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Mar-04-2021
11:05:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNRTRInitial Entry
5.d
Date Location User Value Reason
Mar-04-2021
11:06:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BS20P
LInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-04-2021
11:06:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS20PLInitial Entry
5.e
Date Location User Value Reason
Mar-04-2021
11:06:24ACV0PFEINFP6000 Data Entry:
Sample I BS20PInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917433
Page 130 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)D: M
5.e Sample ID
Date Location User Value Reason
Mar-04-2021
11:06:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS20PMInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917434
Page 131 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-07-2020
13:48:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020
13:48:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020
13:48:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917435
Page 132 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917436
Page 133 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917437
Page 134 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917438
Page 135 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
15:45:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-08-2021
11:29:35
(UTC-05:00)ACV0PFEINFP6000 Query 1: Answer
edplease review
revised SAE
submitted
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917439
Page 136 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time
(US & Canada)3/5/2021
Mar-05-2021
15:03:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL -
event term is
Acute
Cholecystitis;
however, SAE
report
(#202123691)
event term is
Gallstones.
Please review,
harmonize
reporting, and
update where
applicable
Mar-05-2021
10:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ACUTE CHOLE
CYSTITISChanged
Information
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
GALLSTONESInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021
15:46:05ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917440
Page 137 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time
(US & Canada)
Mar-08-2021
11:29:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edplease review
revised SAE
submitted
3/5/2021
Mar-05-2021
15:04:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - End
date is 05 Feb
2021; however,
SAE report
(#2021236691)
end date is 15
Feb 2021.
Please review
end date,
harmonize
reporting, and
update where
applicable
Mar-05-2021
10:50:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/5/2021 10:10Changed
Information
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021 16:0
0Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917441
Page 138 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
10:51:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/8/2021 14:
32Changed
Information
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/15/2021 16
:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917442
Page 139 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
prevent above outcomes).
Date Location User Value Reason
Mar-08-2021
15:48:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Close
dQuery closed; will
follow for
requested COVID
test information.
Mar-08-2021
11:50:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ans
weredupdated SAE
submitted
confirming
negative
COVID-19 test
occurring during
this event
Mar-08-2021
04:29:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delet
edClose Auto Query
Mar-05-2021
15:05:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Open
edClinical COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2021236691] to
document if
COVID testing was
performed
(YES/NO or info
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917443
Page 140 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
not available) and
if yes, the date and
results.
Mar-05-2021
10:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cand
idateFor AE ACUTE
CHOLECYSTITIS:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cand
idateFor AE
GALLSTONES:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this seriou
s event assoc
iated with co
ngenital ano
maly or birth
defect?
NO
Did this serio
us event resuInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917444
Page 141 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
lt in death?
NO
Did this serio
us event requ
ire or prolon
g hospitalizat
ion?
YES
Did this serio
us event resu
lt in persisten
t or significa
nt disability/i
ncapacity?
NO
Is this seriou
s event life th
reatening?
NO
Other medica
lly important
serious event
NO
8. Is this adverse event the result of a study Medication Error?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917445
Page 142 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
OBESE,DIA
BETES,BILE
DUCTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917446
Page 143 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917447
Page 144 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-03-2021
15:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021
04:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021236691Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0917448
Page 145 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
POST CHOLECYS
TECTOMY ABSC
ESSInitial Entry
4. Start Date Time:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917449
Page 146 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917450
Page 147 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
prevent above outcomes).
Date Location User Value Reason
Mar-09-2021
00:27:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Delet
edClose Auto Query
Mar-08-2021
16:00:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edevent now entered on AE
CRF
Mar-08-2021
14:15:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clos
edResponse satisfies query
Mar-08-2021
11:32:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredChanged data per query
Mar-08-2021
11:31:21
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query
3: Open
edIs this adverse event
serious?' is reported 'Yes',
but at least one seriousness
criteria is missing. Please
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917451
Page 148 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(US &
Canada)review and update as
appropriate.
Mar-08-2021
11:31:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Cand
idateFor AE POST
CHOLECYSTECTOMY
ABSCESS: Response to "Is
the adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number" is
blank.
Mar-08-2021
11:31:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredNew Information
Mar-08-2021
11:31:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
YES
Did th
is seri
ous ev
ent re
quire
or pro
long h
ospita
lizatio
n?
YESNew Information
Mar-08-2021 ACV0PFEINFP6000 Query SAE
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917452
Page 149 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
05:42:11
(UTC-05:00)
Eastern Time
(US &
Canada)1: Open
edRECON:AER#2021241699
Post cholecystectomy
abscess(onset date:
12Feb2021)was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-08-2021
14:29:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies
query
Mar-08-2021
11:31:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0917453
Page 150 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-08-2021
11:31:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
Mar-08-2021
00:38:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Is this
adverse event
the result of a
study
Medication
Error? If Yes,
record the
type of
medication
error on the
Medication
Error Log." is
missing.
Kindly
review and
update.
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917454
Page 151 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
OTHER
If Other, specify
:
CHOLECYS
TECTOMY
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021
13:26:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-09-2021
14:26:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edChanged
Information
Mar-09-2021
14:26:26ACV0PFEINFP6000 Data Entry:
YESChanged
Information
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917455
Page 152 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time
(US & Canada)
Mar-08-2021
16:02:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - SAE
report
(#2021241699)
states subject
received
treatment for
post-op abscess
for several days.
Please clarify if
subject received
antibiotics (or
other
medication); if
so, update Med
given? to Yes,
and update SAE
with treatment
information
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021
10:50:06ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917456
Page 153 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021
10:50:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-09-2021
00:27:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021241699Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0917457
Page 154 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STEATOHEPATITI
SInitial Entry
4. Start Date Time:
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917458
Page 155 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/7/2021 13:51Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917459
Page 156 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
prevent above outcomes).
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917460
Page 157 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
DIET, OBESI
TY, METAB
OLIC
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021
10:53:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged
Information
Mar-05-2021
10:53:05ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917461
Page 158 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021
10:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917462
Page 159 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021
13:23:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917463
Page 160 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021
10:44:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-09-2021
09:16:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-08-2021
13:23:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917464
Page 161 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
complete this
date.
Feb-08-2021
13:23:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have received
only placebo at
Vaccination 1/2Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0917465
Page 162 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-09-2021
10:44:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021
10:44:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917466
Page 163 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020
13:48:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020
13:52:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-21-2020
13:49:35
(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-07-2020
13:48:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-21-2020
13:52:05ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917467
Page 164 of 165
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-21-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917468
Page 165 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
12:01:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e1f\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917469