Document text
Page 1 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972698
Page 2 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972699
Page 3 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10971087]
2.Birth Date: 1961
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:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972700
Page 4 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972701
Page 5 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Done
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Done
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972702
Page 6 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972703
Page 7 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gall bladder removal]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendectomy]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1978
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetes mellitus]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: Mar/2/2020
Ongoing: YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972704
Page 8 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Essential hypertension]
Start Date: Mar/2/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: Mar/2/2020
Ongoing: YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972705
Page 9 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [190.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972706
Page 10 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [248947]
3.Randomization Group: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972707
Page 11 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN6B1D]
5.bSample ID [BN6B1F]
5.cSample ID [BN6B1G]
5.dSample ID [BL9X6P]
5.eSample ID [BL9X6R]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972708
Page 12 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN6B15]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972709
Page 13 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/2/2020 09:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972710
Page 14 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972711
Page 15 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972712
Page 16 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972713
Page 17 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6B5R]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972714
Page 18 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 10:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972715
Page 19 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972716
Page 20 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
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 [BPVCKN]
5.bSample ID [BPVCKP]
5.cSample ID [BPVCKR]
5.dSample ID [BL9XF1]
5.eSample ID [BL9XF2]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972717
Page 21 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972718
Page 22 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972719
Page 23 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972720
Page 24 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972721
Page 25 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972722
Page 26 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972723
Page 27 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972724
Page 28 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972725
Page 29 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972726
Page 30 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972727
Page 31 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972728
Page 32 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972729
Page 33 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972730
Page 34 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972731
Page 35 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identif
ierAdverse Eve
ntStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Dental Infecti
on Nov/19/2020 UNK:
UNK NO
End Date Time:
Dec/7/2020 UNK:UNK
Repeating
Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972732
Page 36 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[Dental Infection]
4.Start Date Time: Nov/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/7/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
YES
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
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972733
Page 37 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[Infected tooth]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020466244]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972734
Page 38 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972735
Page 39 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error
associated with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972736
Page 40 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972737
Page 41 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972738
Page 42 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applica
ble Repeating
Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972739
Page 43 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972740
Page 44 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Start Date Form Instance
1.Not Applica
ble Not Applicable Not Applicable Not Applicab
le Not Applica
ble Repeating
Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972741
Page 45 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972742
Page 46 of 204
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972743
Page 47 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972744
Page 48 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972745
Page 49 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972746
Page 50 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972747
Page 51 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972748
Page 52 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972749
Page 53 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972750
Page 54 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972751
Page 55 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972752
Page 56 of 204
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972753
Page 57 of 204
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972754
Page 58 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972755
Page 59 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972756
Page 60 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972757
Page 61 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972758
Page 62 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BP2RWL]
5.bSample ID [BP2RWM]
5.cSample ID [BP2RWN]
5.dSample ID [BHGTG1]
5.eSample ID [BHGTG2]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972759
Page 63 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BP2RWF]
5.bSample ID [BHGTG2 ]
5.cSample ID [BP2RWL ]
5.dSample ID [BP2RWM ]
5.eSample ID [BP2RWN ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972760
Page 64 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 09:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972761
Page 65 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972762
Page 66 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/16/2021
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 [BP2S13]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972763
Page 67 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 08:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972764
Page 68 of 204
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972765
Page 69 of 204
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972766
Page 70 of 204
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972767
Page 71 of 204
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972768
Page 72 of 204
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972769
Page 73 of 204
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972770
Page 74 of 204
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972771
Page 75 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/23/2020
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972772
Page 76 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972773
Page 77 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Feb-24-2021 19:19:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972774
Page 78 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-02-2020 20:24:42 (UTC-05:00) Eastern
Time (US & Canada)Incomplete
Not Done
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972775
Page 79 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972776
Page 80 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972777
Page 81 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972778
Page 82 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972779
Page 83 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972780
Page 84 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972781
Page 85 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972782
Page 86 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972783
Page 87 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972784
Page 88 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972785
Page 89 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
10Nov-24-2020 14:58:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972786
Page 90 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972787
Page 91 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972788
Page 92 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972789
Page 93 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972790
Page 94 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972791
Page 95 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 14:59:20 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972792
Page 96 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972793
Page 97 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972794
Page 98 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972795
Page 99 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972796
Page 100 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972797
Page 101 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972798
Page 102 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972799
Page 103 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972800
Page 104 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972801
Page 105 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972802
Page 106 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
10Nov-24-2020 14:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972803
Page 107 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972804
Page 108 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972805
Page 109 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972806
Page 110 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972807
Page 111 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972808
Page 112 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972809
Page 113 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-24-2020 15:00:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972810
Page 114 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-24-2020 15:00:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972811
Page 115 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-24-2020 15:00:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972812
Page 116 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-24-2020 15:00:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972813
Page 117 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormJan-27-2021 13:04:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0972814
Page 118 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Feb-24-2021 19:19:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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 11:34:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Jan-29-2021 11:57:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-28-2021 11:08:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972815
Page 119 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Tom
Christensen Approved Jan-27-2021 21:03:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-27-2021 13:02:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Jan-20-2021 20:58:06 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-24-2020 14:57:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Oct-27-2020 20:16:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972816
Page 120 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972817
Page 121 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020 20:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020 20:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972818
Page 122 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 20:23:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972819
Page 123 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 20:22:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10971087Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 20:22:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 20:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 20:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 20:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972820
Page 124 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 20:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972821
Page 125 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020 20:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 20:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 20:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972822
Page 126 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 20:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Gall bladder re
moval
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/
2003Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 20:28:33
(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
Dec-02-2020 18:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 11:48:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-01-2020 19:07:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINICAL Thank
you. Diabetes has
start date of
02Mar2020;
however, in SAE
Med hx the duration
is longer (start date
of ?? 2018). Please
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972823
Page 127 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
review, harmonize
reporting, and
update in the
appropriate location
Dec-01-2020 09:23:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-30-2020 12:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL SAE
report has Diabetes
as past med Hx;
however, this
condition is not
listed (also, no
report of HTN).
Please review for
clinical relevance to
SAE of dental
infection, and
update the Med Hx
as appropriate
Sep-02-2020 20:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gall bladder removalInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 20:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 20:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.b
Date Location User Value Reason
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972824
Page 128 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-02-2020 20:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Appendectomy
Start Date: UNK/UNK/197
8
Ongoing: NO
End Date:
UNK/UNK/
1978Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 20:29:17
(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
Sep-02-2020 20:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AppendectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 20:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1978Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 20:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1978Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972825
Page 129 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c
Date Location User Value Reason
Dec-02-2020 11:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:diabetes mell
itus
Start Date: UNK/UNK/2
018
Ongoing: YESChanged
Information
Dec-01-2020 09:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:diabetes mell
itus
Start Date: Mar/2/2020
Ongoing: YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972826
Page 130 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Dec-01-2020 09:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-01-2020 09:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diabetes mellitusInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-02-2020 11:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Changed
Information
Dec-01-2020 09:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Dec-01-2020 09:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Dec-01-2020 14:39:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:4
Medical History
Term:Erectile Dysfu
nction
Start Date: Mar/2/2020
Ongoing: YESChanged
Information
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972827
Page 131 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Dec-01-2020 09:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:ED
Start Date: Mar/2/202
0
Ongoing: YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972828
Page 132 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Dec-01-2020 09:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-01-2020
16:20:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
Dec-01-2020
14:39:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredChanged
Information
Dec-01-2020
14:39:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Erectile Dysf
unctionChanged
Information
Dec-01-2020
11:43:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Op
enedClarify the term
ED as follows.
Please spell out the
abbreviation ED as
it has multiple
meanings. Are you
reporting
EXERTIONAL
DYSPNEA?
ERECTILE
DYSFUNCTION?
Other? Please
update the
verbatim term to
clarify. Thank you.
Dec-01-2020
09:21:48
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
EDInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972829
Page 133 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time
(US & Canada)
1.d Start Date:
Date Location User Value Reason
Dec-01-2020 09:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Dec-01-2020 09:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Dec-01-2020 09:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Essential hypert
ension
Start Date: Mar/2/2020
Ongoing: YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972830
Page 134 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Dec-01-2020 09:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-01-2020 09:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Essential hypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Dec-01-2020 09:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Dec-01-2020 09:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Dec-01-2020 09:23:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:GERD
Start Date: Mar/2/202
0
Ongoing: YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972831
Page 135 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.f Line/MH Number:
Date Location User Value Reason
Dec-01-2020 09:23:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-01-2020 09:23:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.f Start Date:
Date Location User Value Reason
Dec-01-2020 09:23:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Dec-01-2020 09:23:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972832
Page 136 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
190.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.3Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972833
Page 137 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.1
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 20:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972834
Page 138 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 20:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020 06:03:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 11:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-04-2020 11:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
248947Transcription Error
Sep-04-2020 04:56:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS
Reconciliation:
Randomization
number recorded at
impala 248947 is
not matching with
number recorded at
inform. Please
review and update
data as appropriate.
Else clarify. Thank
you.
Sep-02-2020 20:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
248447Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972835
Page 139 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 12:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 12:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 12:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 12:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 12:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 12:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B1DInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972836
Page 140 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 12:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B1DInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 12:55:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B1FInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 12:55:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B1FInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 12:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B1GInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 12:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B1GInitial Entry
5.d
Date Location User Value Reason
Sep-04-2020 08:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9X6PInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972837
Page 141 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Sep-04-2020 08:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9X6PInitial Entry
5.e
Date Location User Value Reason
Sep-04-2020 08:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9X6RInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-04-2020 08:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9X6RInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972838
Page 142 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 12:58:09
(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-03-2020 12:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 12:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 12:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B15Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972839
Page 143 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 12:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B15Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972840
Page 144 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 09:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 20:27:08
(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-02-2020 20:27:08
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972841
Page 145 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-02-2020 20:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972842
Page 146 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User ValueReason
Sep-18-2020
04:36:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Sep-17-2020
16:04:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Sep-17-2020
16:04:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO -
REA
CTO
GENI
CITY
E-DI
ARY
NOT
COLL
ECTE
D FO
R THI
S SU
BJEC
TTranscription Error
Sep-16-2020
03:11:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM1: The page is
unfreeze. Per
response please
consider to update
the data. Thank you.
Sep-15-2020
16:28:45ACV0PFEINFP6000 Query
1: AnFORM IS STILL
FROZEN
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972843
Page 147 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00)
Eastern Time
(US &
Canada)swere
d
Sep-15-2020
06:06:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: The form is not
frozen now. Kindly
update accordingly.
Sep-14-2020
17:04:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dTranscription error.
Answer should be
no. Unable to change
answer.
Sep-14-2020
12:50:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedeDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
"Yes" however
VAX1 eDiary records
are not available for
the subject . Please
verify and update.
Else, confirm in
query response
appropriately.
Sep-02-2020
20:27:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YES -
REA
CTO
GENI
CITY
E-DI
ARY
COLL
ECTE
D FOInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972844
Page 148 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
R THI
S SU
BJEC
T
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972845
Page 149 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 16:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972846
Page 150 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972847
Page 151 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-24-2020 16:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972848
Page 152 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 16:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 16:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 16:52:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 16:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 16:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 16:52:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6B5RInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972849
Page 153 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 16:52:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6B5RInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972850
Page 154 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020 10:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972851
Page 155 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 16:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972852
Page 156 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 11:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972853
Page 157 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 11:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 11:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 11:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 11:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 11:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 11:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCKNInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972854
Page 158 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 11:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVCKNInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 11:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCKPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 11:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVCKPInitial Entry
5.c
Date Location User Value Reason
Oct-23-2020 11:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCKRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 11:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVCKRInitial Entry
5.d
Date Location User Value Reason
Oct-23-2020 11:48:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XF1Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972855
Page 159 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Oct-23-2020 11:48:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9XF1Initial Entry
5.e
Date Location User Value Reason
Oct-23-2020 11:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XF2Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-23-2020 11:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9XF2Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972856
Page 160 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-23-2020 11:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 11:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 11:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972857
Page 161 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972858
Page 162 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dental InfectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-22-2020 22:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-21-2020 09:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Follow-up was
submitted.
Dec-18-2020 12:03:31
(UTC-05:00) EasternACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank you;
please submit the
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972859
Page 163 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) event end date to
the SAE in a safety
followup
Dec-16-2020 14:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-16-2020 14:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/7/2020 UNK:UNKNew Information
Dec-15-2020 21:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Please
report if subject has
successfully
completed all
treatment and event
end date, if
available, to both
AE and SAE
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-06-2020 12:52:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972860
Page 164 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
requested COVID
test info
Dec-03-2020 13:43:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered data per subject
cannot not be
confirmed until
hospital records ore
received.
Dec-02-2020 19:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
COVID test was
performed is known,
please submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Dec-02-2020 08:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Patient states that no
test was performed
due to the nature of
the illness.
Dec-01-2020 19:09:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical Thank you.
If a COVID test was
performed during
Hosp (reported by
Subject) with
negative result;
please submit this
pertinent test
information
including subject as
the source to the
SAE.
Dec-01-2020 09:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered MEDICAL
RECORDS HAVE
NOT BEEN
OBTAINED. PER
PATIENT, HE WAS
COVID
NEGATIVE.
Nov-30-2020 00:09:39
(UTC-05:00) EasternACV0PFEINFP6000 Query 2: Opened Clinical COVID test
status (yes/no)
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972861
Page 165 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020466244] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Nov-25-2020 04:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Dental
Infection: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th 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 disabil
ity/incapacity?
NOInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972862
Page 166 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
YES
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
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Infected toothInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-24-2020 14:57:49 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972863
Page 167 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00) Eastern
Time (US & Canada)YES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-24-2020 14:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020
07:54:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-18-2020
11:32:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered AE update was submitted today.
Dec-18-2020
08:32:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Op
enedSAE RECON: Outcome in SDB
recorded as recovering/resolving.
Please submit a follow up AE form
to update outcome in Safety
database.
Dec-18-2020
07:40:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Ca
ndidateSAE RECON: Outcome in SDB
recorded as recovering/resolving.
Please submit a follow up AE form
to update outcome in Safety
database.
Dec-17-2020
10:35:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered No hospital records received yet,
new information was reported by
subject.
Dec-17-2020
07:29:41
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020466244 ,outcome
was updated to
RECOVERED/RESOLVED on AE
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972864
Page 168 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Canada) CRF while reported as
Recovering/resolving in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form
Dec-16-2020
14:40:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-16-2020
14:40:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDNew Information
Dec-16-2020
14:38:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Dental Infection: Response
to "What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-24-2020
14:57:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-24-2020 14:57:49
(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
Nov-25-2020 04:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020466244Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972865
Page 169 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972866
Page 170 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-24-2020 14:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972867
Page 171 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 14:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 14:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 14:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
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).
Date Location User Value Reason
Nov-24-2020 14:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Nov-24-2020 14:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972868
Page 172 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
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).
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972869
Page 173 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972870
Page 174 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Nov-24-2020 15:00:19
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972871
Page 175 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972872
Page 176 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Nov-24-2020 15:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Nov-24-2020 15:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972873
Page 177 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 13:02:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972874
Page 178 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-27-2021 13:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per other protocol allo
wance(s) and confirmed to hav
e received only placebo at Vacc
ination 1/2Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972875
Page 179 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021 13:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021 13:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972876
Page 180 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 13:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972877
Page 181 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-27-2021 13:04:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/26/2021Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972878
Page 182 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-27-2021 13:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-27-2021 13:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-27-2021 13:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972879
Page 183 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 14:26:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 13:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 13:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 14:26:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWLInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972880
Page 184 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Jan-28-2021
21:34:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-28-2021
16:47:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per
query
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047555;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-27-2021
14:26:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
BP2R
WLInitial Entry
5.b
Date Location User Value Reason
Feb-08-2021 11:34:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWMTranscription Error
Jan-27-2021 14:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: GP2RWMInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972881
Page 185 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.b Sample ID
Date Location User Value Reason
Feb-08-2021 11:34:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP2RWMTranscription Error
Jan-27-2021 14:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GP2RWMInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 14:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWNInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972882
Page 186 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.c Sample ID
Date Location User Value Reason
Jan-28-2021
21:34:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-28-2021
16:47:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per
query
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047557;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-27-2021
14:27:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
BP2R
WNInitial Entry
5.d
Date Location User Value Reason
Jan-27-2021 14:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHGTG1Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972883
Page 187 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Jan-28-2021
21:26:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-28-2021
16:47:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per
query
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047551;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-27-2021
14:41:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
BHGT
G1Initial Entry
5.e
Date Location User Value Reason
Jan-27-2021 14:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHGTG2Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972884
Page 188 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.e Sample ID
Date Location User Value Reason
Jan-28-2021
21:34:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-28-2021
16:47:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per
query
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047553;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-27-2021
14:42:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
BHGT
G2Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972885
Page 189 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 11:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 04:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 13:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 13:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/26/2021Initial Entry
5.a
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972886
Page 190 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Jan-28-2021 16:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWFTranscription Error
Jan-28-2021 11:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHGTG1Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021
21:34:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-28-2021
16:45:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Jan-28-2021
16:45:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
BP2R
WFTranscription Error
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047552;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-28-2021
11:08:40
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Data
Entry:
BHGT
G1Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972887
Page 191 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Canada)
5.b
Date Location User Value Reason
Jan-28-2021 16:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHGTG2Transcription Error
(DELETED)
Jan-28-2021 11:08:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHGTG2Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972888
Page 192 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.b Sample ID
Date Location User Value Reason
Jan-29-2021
01:32:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Close
dResponse satisfies
query
Jan-28-2021
16:45:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BHGT
G2Transcription Error
(DELETED)
Jan-28-2021
16:45:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answ
eredTranscription Error
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW7047554;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Jan-28-2021
11:08:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BHGT
G2Initial Entry
5.c
Date Location User Value Reason
Jan-28-2021 16:46:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWLTranscription Error
(DELETED)
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972889
Page 193 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Jan-28-2021 11:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWLInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021
01:32:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Close
dResponse satisfies
query
Jan-28-2021
16:46:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BP2RW
LTranscription Error
(DELETED)
Jan-28-2021
16:46:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answ
eredTranscription Error
Jan-28-2021
16:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW7047556;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Jan-28-2021
11:09:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BP2RW
LInitial Entry
5.d
Date Location User Value Reason
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972890
Page 194 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Jan-28-2021 16:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWMTranscription Error
(DELETED)
Jan-28-2021 11:09:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWMInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-28-2021 16:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP2RWMTranscription Error
(DELETED)
Jan-28-2021 11:09:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP2RWMInitial Entry
5.e
Date Location User Value Reason
Jan-28-2021 16:46:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWNTranscription Error
(DELETED)
Jan-28-2021 11:09:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RWNInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972891
Page 195 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.e Sample ID
Date Location User Value Reason
Jan-29-2021
01:07:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Close
dResponse satisfies
query
Jan-28-2021
16:46:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BP2RW
NTranscription Error
(DELETED)
Jan-28-2021
16:46:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answ
eredTranscription Error
Jan-28-2021
16:13:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW7047558;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Jan-28-2021
11:09:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BP2RW
NInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0972892
Page 196 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021 09:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972893
Page 197 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-27-2021 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0972894
Page 198 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021 08:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972895
Page 199 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 08:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 08:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021 14:45:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-16-2021 08:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-16-2021 08:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/16/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021 14:45:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2S13Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972896
Page 200 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Feb-16-2021 14:45:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP2S13Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0972897
Page 201 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021 08:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972898
Page 202 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-16-2021 08:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972899
Page 203 of 204
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-23-2020 11:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020 20:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-02-2020 20:25:07
(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-23-2020 11:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
Sep-02-2020 20:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-02-2020 20:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972900
Page 204 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 23:10:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ebc\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0972901