Document text
Page 1 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019998
Page 2 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019999
Page 3 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10931128]
2.Birth Date: /1963
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:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020000
Page 4 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020001
Page 5 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020002
Page 6 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020003
Page 7 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTROPHIC CARDIOMYOPATHY]
Start Date: UNK/UNK/1976
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEPTAL MYECTOMY]
Start Date: Jul/12/2019
Ongoing: NO
End Date:
Jul/12/2019
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020004
Page 8 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [301.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [40.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020005
Page 9 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [258143]
3.Randomization Group: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020006
Page 10 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BP5DDW]
5.bSample ID [BPR6NR]
5.cSample ID [BPR6NP]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020007
Page 11 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BPR6NN]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020008
Page 12 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/11/2020 16:54
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
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020009
Page 13 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020010
Page 14 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020011
Page 15 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020012
Page 16 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SUBJECT NOT VACCINATED DUE TO HAVING HIGH BP. SUB TO F/U
WITH PCP AND/OR CARDIOLOGIST.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020013
Page 17 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/30/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Applicable Comments
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?Not Applicable Comments
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020014
Page 18 of 112
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020015
Page 19 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5HBD]
5.bSample ID [BSHLTK]
5.cSample ID [BSHLTJ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020016
Page 20 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020017
Page 21 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020018
Page 22 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020019
Page 23 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020020
Page 24 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020021
Page 25 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020022
Page 26 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020023
Page 27 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020024
Page 28 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020025
Page 29 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020026
Page 30 of 112
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/18/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020027
Page 31 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020028
Page 32 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020029
Page 33 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020030
Page 34 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 WORSENING HYPERTE
NSION Sep/30/2020 0
0:00 NO
End Date Time:
Oct/21/2020 UNK:UNK
Repeating
Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020031
Page 35 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[WORSENING HYPERTENSION]
4.Start Date Time: Sep/30/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/21/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNDERLYING MEDICAL CONDITION]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020032
Page 36 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020033
Page 37 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020034
Page 38 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020035
Page 39 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020036
Page 40 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020037
Page 41 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020038
Page 42 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020039
Page 43 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020040
Page 44 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020041
Page 45 of 112
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020042
Page 46 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020043
Page 47 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020044
Page 48 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020045
Page 49 of 112
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020046
Page 50 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020047
Page 51 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020048
Page 52 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020049
Page 53 of 112
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Queries
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020050
Page 54 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020051
Page 55 of 112
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020052
Page 56 of 112
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020053
Page 57 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/18/2020
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020054
Page 58 of 112
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020055
Page 59 of 112
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020056
Page 60 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 17:35:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020057
Page 61 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-18-2020 15:36:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020058
Page 62 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-18-2020 15:37:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
6Nov-18-2020 15:36:39 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020059
Page 63 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
11Nov-18-2020 15:36:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020060
Page 64 of 112
***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, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Nov-18-2020 15:33:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Nov-17-2020 17:48:12 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, 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-17-2020 09:15:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Oct-29-2020 08:33:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, 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.
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020061
Page 65 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020 17:35:19
(UTC-06:00) Central 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-11-2020 17:35:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020062
Page 66 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020 17:35:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/11/2020Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020063
Page 67 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 17:35:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10931128Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020 17:35:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020 17:35:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-11-2020 17:35:33
(UTC-06:00) Central 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-11-2020 17:35:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020064
FDA-CBER-2021-5683-1020065
Page 69 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
elevated BP). Please
review if these are
considered adverse
events to be captured
in the CRF
Nov-10-2020 00:12:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate To be tracked for Visit
2 scheduling
Nov-09-2020 15:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SUBJECT WILL BE
RESCHEDULED FOR
VISIT
Nov-07-2020 09:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM2: Thank you for
response, please
consider to update the
data when actual visit
performed.
Oct-15-2020 03:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate DM2: Thank you for
response, please
consider to update the
data when actual visit
performed.
Oct-14-2020 13:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SUBJECT NOT
VACCINATED DUE
TO NEEDING TO
FOLLOW UP WITH
PCP/CARDIOLOGIST
DUE TO ATRIAL
FIBRILATION AND
ELEVATED BP.
Oct-07-2020 08:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thank you for
your response.
However, please keep
the query open until
updates are made. Else
clarify.
Oct-06-2020 07:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered THERE ARE NO
DETAILS TO ENTER
INTO VISIT 2,
SUBJECT WAS NOT
VACCINATED THIS
DAY
Oct-06-2020 04:24:26 ACV0PFEINFP6000 Query 1: Opened DM: Details on visit
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (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)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1020066
Page 70 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00) Central
Time (US & Canada)‘V2VX2L’ are missing.
Kindly consider to
update or else clarify.
Thank you.
Sep-11-2020 17:35:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1020067
Page 71 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020 17:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020 17:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020 17:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020068
Page 72 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020 17:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:HYPERTROPHIC C
ARDIOMYOPATHY
Start Date: UNK/UNK/1976
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020 17:37:11
(UTC-06:00) Central 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
Sep-11-2020 17:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTROPHIC CARDIOMYOP
ATHYInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-11-2020 17:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1976Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020 17:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020069
Page 73 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-11-2020 17:37:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:HYPERTENSI
ON
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020 17:37:20
(UTC-06:00) Central 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-11-2020 17:37:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020 17:37:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020 17:37:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-11-2020 17:37:30
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 3Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020070
Page 74 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) mber:
Medical Histo
ry Term:HYPERCHOLEST
EROLEMIA
Start Date: UNK/UNK/2018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-11-2020 17:37:30
(UTC-06:00) Central 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
Sep-11-2020 17:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-11-2020 17:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-11-2020 17:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-11-2020 17:37:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:SEPTAL MYEC
TOMY
Start Date: Jul/12/2019Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020071
Page 75 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
Jul/12/2019
1.d Line/MH Number:
Date Location User Value Reason
Sep-11-2020 17:37:56
(UTC-06:00) Central 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
Sep-11-2020 17:37:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SEPTAL MYECTOMYInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-11-2020 17:37:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/12/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-11-2020 17:37:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/12/2019Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1020072
Page 76 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 04:54:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-17-2020 10:33:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered OUT OF RANGE
VALUE IS NCS
Sep-12-2020 03:38:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Confirmation
on the out of range
value as clinically
significant or not is
expected. Please
review and confirm.
Thank you.
Sep-11-2020 17:57:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-11-2020 17:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 301 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for lb.
Sep-11-2020 17:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
301.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (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) (6)
(b) (4)
FDA-CBER-2021-5683-1020073
Page 77 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4. Height:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
40.8Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
98.6Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1020074
Page 78 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
7.a Unit:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 17:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1020075
Page 79 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020 17:38:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020 17:38:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
258143Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020076
Page 80 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 17:38:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 17:38:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 17:59:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 17:38:32
(UTC-06:00) Central
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-11-2020 17:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5DDWInitial Entry
5.a Sample ID
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020077
Page 81 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-11-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5DDWInitial Entry
5.b
Date Location User Value Reason
Sep-11-2020 18:00:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6NRInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020 18:00:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6NRInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020 18:00:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6NPInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020 18:00:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6NPInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020078
Page 82 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 17:38:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 17:38:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 18:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 17:38:40
(UTC-06:00) Central
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-11-2020 17:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6NNInitial Entry
5.a Sample ID
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020079
Page 83 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-11-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6NNInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020080
Page 84 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020 16:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020081
Page 85 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7. Route:
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-11-2020 17:38:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020082
Page 86 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020 17:39:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020083
Page 87 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-02-2020 00:39:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-01-2020 10:16:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PLEASE
UNFREEZE FORM
SO THIS MAY BE
DONE.
Nov-26-2020 04:16:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM2: EOT details
are present. If subject
was not vaccinated,
please consider to
remove existing data
on Vaccination CRF
and add form level
'Not Done' comment.
Thanks
Nov-25-2020 14:48:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered VACCINATION
WAS NOT GIVEN
AT V2. V2 VISIT IS
UPDATED.
Nov-23-2020 01:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Kindly
confirm if
vaccination is given
at V2VX2L visit and
other assessments are
performed at this
visit. If yes then
update data on all the
required forms under
‘V2VX2L’ visit as
appropriate. Else
clarify.
Nov-20-2020 17:02:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered WILL UPDATE V2
FORM
Nov-19-2020 05:49:28
(UTC-06:00) CentralACV0PFEINFP6000 Query 1: Opened DM: As per the
previous response on
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (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) (6)
(b) (4)
FDA-CBER-2021-5683-1020084
Page 88 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) V1, kindly verify and
update V2 form.
Thank you.
Nov-18-2020 15:33:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020085
Page 89 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.9
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020086
Page 90 of 112
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-18-2020 15:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020087
Page 91 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 15:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 15:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020 15:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-23-2020 04:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed AF removed from
description
Nov-20-2020 17:03:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-20-2020 17:03:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT NOT VACCINATED D
UE TO HAVING HIGH BP. SUB
TO F/U WITH PCP AND/OR CA
RDIOLOGIST.Transcription Error
Nov-20-2020 05:25:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY:
Elevated BP has been
entered in as an AE
but not the Atrial
Fibrillation. Please
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020088
Page 92 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and clarify
whether this AF
information is to be
added as an AE
Nov-18-2020 15:35:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT NOT VACCINATED D
UE TO BEING IN ATRIAL FIBR
ILLATION AS WELL AS HAVIN
G HIGH BP. SUB TO F/U WITH
PCP AND/OR CARDIOLOGIST.Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020089
Page 93 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-18-2020 15:36:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Sep/30/2020
Reason(s) for Temporary Delay of
Vaccination
FEVER OR ACUTE ILLNESSInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-18-2020 15:36:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-18-2020 15:37:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-18-2020 15:36:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-18-2020 15:36:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020090
Page 94 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 15:37:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020091
Page 95 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 15:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 15:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 08:38:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-05-2021 16:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered ENTERIES ADDED
Jan-05-2021 12:17:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened HOLDS: For Visit 3,
the lab has received
a sample with a
barcode of BSHLTJ
and BSHLTK;
however, the
barcodes have not
been reported for
this Visit. Please
review and update as
appropriate.
Otherwise, please
clarify.
Nov-19-2020 09:48:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020092
Page 96 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-19-2020 03:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-18-2020 15:37:43
(UTC-06:00) Central
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.
Nov-18-2020 15:37:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020 09:48:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5HBDInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020 09:48:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5HBDInitial Entry
5.b
Date Location User Value Reason
Jan-05-2021 16:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHLTKInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020093
Page 97 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.b Sample ID
Date Location User Value Reason
Jan-07-2021
01:59:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies
query
Jan-06-2021
14:22:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
AnsweredENTRY
UPDATED
Jan-05-2021
22:46:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1:
OpenedDMW6706090;The
barcode BSHLTK
is recorded for two
subjects 10931128
and 10931143,
please review and
update as
appropriate.
Jan-05-2021
16:00:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
BSHLTKInitial Entry
5.c
Date Location User Value Reason
Jan-05-2021 16:00:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHLTJInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-05-2021 16:00:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSHLTJInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020094
Page 98 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-18-2020 15:38:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-18-2020 15:38:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-01-2020
14:59:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2:
ClosedAuto closed by
Validation Check:
VC_DS001_25
Dec-01-2020
11:24:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1:
ClosedResponse satisfies
query
Dec-01-2020
10:15:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dAE WILL BE
UPDATED.
Nov-30-2020
20:19:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2:
OpenedDMW6279323;Status
is reported as
Adverse Event, but
there is no Adverse
Event with 'Latest
Action Taken with
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020095
Page 99 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as appropriate.
Nov-30-2020
16:08:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dTranscription Error
Nov-30-2020
16:08:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
ADVER
SE EVE
NTTranscription Error
Nov-26-2020
06:43:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1:
Reissue
d:Opene
dCLLINQUERY: EOT
due to Worsening
Hypertension: Please
update status on EOT
page to ADVERSE
EVENT and on the
AE log update q10
'Last Action Taken
with study treatment'
to DRUG
WITHDRAWN
Nov-25-2020
14:47:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
dSUBJECT WAS
NOT VACCINATED
DUE TO
PROVIDER
DISCRETION OF
WORSENING
HYPERTENSTION.
Nov-23-2020
07:27:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1:
OpenedCLINQUERY: End
of treatment status is
reported as
COMPLETED.
However, second
vaccination was not
given. Please review
status field and
update to reflect
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020096
Page 100 of 112
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
reason for EOT.
Nov-18-2020
15:38:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
COMPL
ETEDInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020097
Page 101 of 112
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-17-2020 09:15:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020098
Page 102 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 09:15:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 09:15:58
(UTC-06:00) Central 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-17-2020 09:15:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WORSENING HYPERTENSIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 09:15:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-01-2020 10:15:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/21/2020 UNK:UNKTranscription Error
Nov-23-2020 01:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Nov-20-2020 17:05:54
(UTC-06:00) CentralACV0PFEINFP6000 Query 1: Answered FORM UPDATED
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020099
Page 103 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
Nov-17-2020 23:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete item # 6 to
14. Thank you.
Nov-17-2020 09:15:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-20-2020 17:07:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:Transcription Error
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1020100
Page 104 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
OTHER
If Other, specify:
UNDERLYING MEDICAL
CONDITION
Nov-20-2020 17:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
UNDERLYINGF MEDICAL
CONDITIONInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020
11:23:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2:
ClosedResponse satisfies
query
Dec-01-2020
10:15:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredTranscription Error
Dec-01-2020
10:15:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
DRUG W
ITHDRA
WNTranscription Error
Dec-01-2020
05:03:23
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Hayley Wyper Query 2:
OpenedCLINQUERY:
EOT tab reported
subject was
discontinued from
treatment due to
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020101
Page 105 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Canada) worsening
hypertension. If
correct, please
review this entry on
the AE line.
Nov-25-2020
20:34:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_AE001_32
Nov-25-2020
14:46:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription Error
Nov-25-2020
14:46:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOT AP
PLICAB
LETranscription Error
Nov-22-2020
23:10:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1:
OpenedDMW5441224;The
Latest Action to
Study Treatment is
DRUG
WITHDRAWN,
but the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Nov-20-2020
17:05:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
DRUG W
ITHDRA
WNInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020102
Page 106 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Dec-01-2020
14:59:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedAuto closed by
Validation Check:
VC_AE001_35
Dec-01-2020
10:16:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dEND DATE HAS BEEN
UPDATED.
Nov-25-2020
20:25:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW6245515;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Nov-25-2020
14:46:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Clo
sedClose Auto Query
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020103
Page 107 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-25-2020
14:46:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RED/
RESO
LVEDNew Information
Nov-20-2020
17:05:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedFor AE WORSENING
HYPERTENSION:
Response to "What was
the outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided or
"Is the adverse event still
ongoing?" is marked
"Yes".
Nov-20-2020
17:05:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
UNK
NOW
NInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-20-2020 17:05:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020104
Page 108 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 13:53:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020105
Page 109 of 112
***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, Queries
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-13-2021 00:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Vaccination 3 is
reported in IRT,
however, this form
indicates that the
participant was not
confirmed as
placebo. Please
review, reconcile the
response with the
source as well as
enter the Vax 3
and/or Vax 4 visits,
if completed or
explain otherwise.
Feb-26-2021 13:54:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020106
Page 110 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-26-2021 13:53:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-26-2021 13:53:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020107
Page 111 of 112
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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1. Subject Status
Date Location User Value Reason
Nov-30-2020 16:08:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-18-2020 15:38:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-11-2020 17:38:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-11-2020 17:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-30-2020 16:08:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/18/2020Transcription Error
Nov-18-2020 15:38:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
Sep-11-2020 17:38:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
Sep-11-2020 17:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020108
Page 112 of 112
***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, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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1. Casebook Signature
Date Location User Value Reason
Oct-28-2020 15:11:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f50\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020109