Document text
Page 1 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808498
Page 2 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808499
Page 3 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11451076]
2.Birth Date: /1956
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808500
Page 4 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808501
Page 5 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808502
Page 6 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808503
Page 7 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SHINGLES VACCINE DOSE 1 [vaccination]]
Start Date: Feb/13/2020
Ongoing: NO
End Date:
Feb/13/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SHINGLES VACCINE DOSE 2 [vaccination]]
Start Date: Jul/25/2020
Ongoing: NO
End Date:
Jul/25/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SHOULDER PAIN]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808504
Page 8 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [163.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808505
Page 9 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [252393]
3.Randomization Group: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808506
Page 10 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[1.8ml and 0.4ml collected for two retain aliquots]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPJ1BS]
5.bSample ID [BPJ1BT]
5.cSample ID [BPJ1BV]
5.dSample ID [BP1KDP]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808507
Page 11 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1KDC]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808508
Page 12 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 12:30
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
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808509
Page 13 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808510
Page 14 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808511
Page 15 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808512
Page 16 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[the volunteer has been diagnosed with Parkinsonism, he is withdrawn from the
intervention, he did not get the second vaccine, but he is following up for drug
immunogencitiy, safety and efficacy]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1L9D]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808513
Page 17 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808514
Page 18 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808515
Page 19 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [BP1LD2]
5.bSample ID [BNW4WP]
5.cSample ID [BNW4WR]
5.dSample ID [BNW4WS]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808516
Page 20 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808517
Page 21 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808518
Page 22 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808519
Page 23 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808520
Page 24 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808521
Page 25 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808522
Page 26 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808523
Page 27 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808524
Page 28 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808525
Page 29 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808526
Page 30 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808527
Page 31 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808528
Page 32 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808529
Page 33 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808530
Page 34 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 parkinsonis
m Sep/18/2020 UNK:
UNK YES Repeating
Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808531
Page 35 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[parkinsonism]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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:
[natural progression of parkinsonism]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808532
Page 36 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808533
Page 37 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808534
Page 38 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808535
Page 39 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.1 VACCINATIONS NO flu shot Oct/6/20
20 Repeating
Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808536
Page 40 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[flu shot]
5.Date: Oct/6/2020
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808537
Page 41 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808538
Page 42 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808539
Page 43 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808540
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808541
Page 45 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808542
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808543
Page 47 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808544
Page 48 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808545
Page 49 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808546
Page 50 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808547
Page 51 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808548
Page 52 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808549
Page 53 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808550
Page 54 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808551
Page 55 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808552
Page 56 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808553
Page 57 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808554
Page 58 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808555
Page 59 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808556
Page 60 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808557
Page 61 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNW4T4]
5.bSample ID [BNW4T5]
5.cSample ID [BNW4T6]
5.dSample ID [BM9C1H]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808558
Page 62 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C1F]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808559
Page 63 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 11:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808560
Page 64 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808561
Page 65 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C3N]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808562
Page 66 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 11:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808563
Page 67 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808564
Page 68 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/9/2021
3.Comments: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808565
Page 69 of 175
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808566
Page 70 of 175
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808567
Page 71 of 175
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808568
Page 72 of 175
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808569
Page 73 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/9/2021 Comments
2.Phase of Disposition: OPEN LABEL TREATMENT Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808570
Page 74 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/21/2020
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808571
Page 75 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808572
Page 76 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808573
Page 77 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-06-2020 11:03:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808574
Page 78 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808575
Page 79 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
1Oct-06-2020 10:45:34 (UTC-05:00) Eastern
Time (US & Canada)the volunteer has been diagnosed with
Parkinsonism, he is withdrawn from the
intervention, he did not get the second vaccine,
but he is following up for drug immunogencitiy,
safety and efficacy
Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808576
Page 80 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808577
Page 81 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808578
Page 82 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
4Oct-06-2020 10:45:54 (UTC-05:00) Eastern
Time (US & Canada)the volunteer has been diagnosed with
Parkinsonism, he is withdrawn from the
intervention, he did not get the second vaccine,
but he is following up for drug immunogencitiy,
safety and efficacy
Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808579
Page 83 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808580
Page 84 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
6Oct-06-2020 10:46:08 (UTC-05:00) Eastern
Time (US & Canada)the volunteer has been diagnosed with
Parkinsonism, he is withdrawn from the
intervention, he did not get the second vaccine,
but he is following up for drug immunogencitiy,
safety and efficacy
Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808581
Page 85 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808582
Page 86 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808583
Page 87 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808584
Page 88 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808585
Page 89 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
11Oct-21-2020 09:28:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808586
Page 90 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 15:10:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808587
Page 91 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-19-2021 15:10:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808588
Page 92 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 15:11:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808589
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-19-2021 15:11:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808590
Page 94 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 15:12:57 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808591
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormMar-09-2021 11:29:07 (UTC-05:00) Eastern
Time (US & Canada)
FormMar-01-2021 12:20:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808592
Page 96 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Mar-09-2021 11:29:07 (UTC-05:00) Eastern
Time (US & Canada)
1Mar-01-2021 12:20:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808593
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Mar-09-2021 11:29:07 (UTC-05:00) Eastern
Time (US & Canada)
2Mar-01-2021 12:20:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808594
Page 98 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Mar-09-2021 11:29:07 (UTC-05:00) Eastern
Time (US & Canada)
3Mar-01-2021 12:20:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808595
Page 99 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Mar-09-2021 11:29:07 (UTC-05:00) Eastern
Time (US & Canada)
4Mar-01-2021 12:20:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808596
Page 100 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 Jan-25-2021 10:23:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 16:30:09 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-19-2021 15:08:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 15:08:14 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808597
Page 101 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-06-2020 11:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-06-2020 11:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808598
Page 102 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-06-2020 11:02:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/4/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808599
Page 103 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 13:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11451076Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 13:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-06-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-06-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-06-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASIANInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808600
Page 104 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-06-2020 11:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808601
Page 105 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-06-2020 11:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-06-2020 11:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-06-2020 11:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808602
Page 106 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-08-2020 09:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:SHINGLES VACCIN
E DOSE 1 [vaccinati
on]
Start Date
:Feb/13/2020
Ongoing: NO
End Date:
Feb/13/2020Updated according
to query
Sep-06-2020 11:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:SHINGLES VACC
INE DOSE 1
Start Date: Feb/13/2020
Ongoing: NO
End Date:
Feb/13/2020Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-06-2020 11:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020
10:48:18
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808603
Page 107 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Eastern Time
(US & Canada)
Sep-08-2020
09:42:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredUpdated
according to query
Sep-08-2020
09:42:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SHINGLES
VACCINE
DOSE 1 [va
ccination]Updated
according to query
Sep-06-2020
20:12:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Op
enedClarify
SHINGLES
VACCINE DOSE
1 as follows...Are
you reporting
procedure
VACCINATION?
Or ALLERGIC
REACTION to
vaccine? Or
INTERACTION
WITH? Or other?
If so, update the
verbatim term as
such. If reporting
therapeutic
administration,
move the term to
drug page. Thank
you.
Sep-06-2020
11:20:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SHINGLES
VACCINE
DOSE 1Initial Entry
1.a Start Date:
Date Location User Value Reason
Sep-06-2020 11:20:54
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Feb/13/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808604
Page 108 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
1.a Ongoing:
Date Location User Value Reason
Sep-06-2020 11:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/13/2020Initial Entry
1.b
Date Location User Value Reason
Sep-08-2020 09:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:SHINGLES VACCI
NE DOSE 2 [vaccina
tion]
Start Date
:Jul/25/2020
Ongoing: NO
End Date:
Jul/25/2020Updated according
to query
Sep-06-2020 11:34:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:SHINGLES VACC
INE DOSE 2
Start Date: Jul/25/2020
Ongoing: NO
End Date:
Jul/25/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808605
Page 109 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-06-2020 11:34:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020
10:48:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
Sep-08-2020
09:42:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredUpdated
according to query
Sep-08-2020
09:42:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SHINGLES
VACCINE
DOSE 2 [va
ccination]Updated
according to query
Sep-06-2020
20:12:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Op
enedClarify
SHINGLES
VACCINE DOSE
2 as follows...Are
you reporting
procedure
VACCINATION?
Or ALLERGIC
REACTION to
vaccine? Or
INTERACTION
WITH? Or other?
If so, update the
verbatim term as
such. If reporting
therapeutic
administration,
move the term to
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808606
Page 110 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
drug page. Thank
you.
Sep-06-2020
11:34:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SHINGLES
VACCINE
DOSE 2Initial Entry
1.b Start Date:
Date Location User Value Reason
Sep-06-2020 11:34:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/25/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-06-2020 11:34:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/25/2020Initial Entry
1.c
Date Location User Value Reason
Sep-06-2020 11:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:SHOULDER P
AIN
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808607
Page 111 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-06-2020 11:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-06-2020 11:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SHOULDER PAINInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-06-2020 11:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-06-2020 11:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808608
Page 112 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
163.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.4Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808609
Page 113 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-06-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808610
Page 114 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-06-2020 11:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-06-2020 11:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
252393Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808611
Page 115 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 22:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 22:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 22:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 22:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 22:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-07-2020 22:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1.8ml and 0.4ml collected for tw
o retain aliquotsInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808612
Page 116 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Sep-07-2020 22:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ1BSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 22:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ1BSInitial Entry
5.b
Date Location User Value Reason
Sep-07-2020 22:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ1BTInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-07-2020 22:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ1BTInitial Entry
5.c
Date Location User Value Reason
Sep-07-2020 22:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ1BVInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020 22:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ1BVInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808613
Page 117 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d
Date Location User Value Reason
Sep-07-2020 22:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1KDPInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-07-2020 22:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1KDPInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808614
Page 118 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 22:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 22:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 22:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 22:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 22:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 22:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1KDCInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808615
Page 119 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 22:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1KDCInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808616
Page 120 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 12:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808617
Page 121 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-06-2020 11:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808618
Page 122 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-06-2020 11:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808619
Page 123 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-09-2020
06:22:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedAs per site
confirmation -
updated PD tracker
Oct-08-2020
10:37:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dthe volunteer has
been diagnosed with
Parkinsonism, he is
withdrawn from the
intervention, he did
not get the second
vaccine, but he is
following up for
drug
immunogencitiy,
safety and efficacy
Oct-08-2020
03:23:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 9
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Oct-06-2020
10:41:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Del
etedInitial Entry
Oct-06-2020
10:41:26
(UTC-05:00)ACV0PFEINFP6000 Data
Entry
:Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808620
Page 124 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Eastern Time
(US &
Canada)Oct/6/
2020
Oct-01-2020
10:55:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Candi
dateIt will be tracked till
V2 is performed.
Sep-30-2020
11:38:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dWE ARE
CURRENTLY
WAITING TO SEE
WHEN THE
VOLUNTEER CAN
COME IN FOR
VISIT
Sep-29-2020
09:56:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedDM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808621
Page 125 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808622
Page 126 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-06-2020 10:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808623
Page 127 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 10:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 10:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 10:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020New Information
Oct-06-2020 10:46:33
(UTC-05:00) Eastern
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
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808624
Page 128 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-28-2020 13:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-27-2020 15:33:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE log is filled
Oct-20-2020 21:29:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
New diagnosis of
Parkinsonism has
been noted, yet no
AE has been
reported. Please
confirm and update
the AE CRF as
applicable.
Oct-06-2020 10:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
the volunteer has been diagnos
ed with Parkinsonism, he is wit
hdrawn from the intervention,
he did not get the second vacci
ne, but he is following up for d
rug immunogencitiy, safety an
d efficacyInitial Entry
5.a
Date Location User Value Reason
Oct-08-2020 10:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1L9DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 10:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1L9DInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808625
Page 129 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020 07:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-21-2020 09:29:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered form level NOt
done is selected
now thank u
Oct-21-2020 04:46:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to update
this form if require
else mark as Not
done by selecting
form level
comment instead
item level. Thank
you.
Oct-06-2020 10:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808626
Page 130 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-06-2020 10:45:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-06-2020 10:46:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808627
Page 131 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
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
Oct-21-2020 09:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-20-2020 11:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-19-2020 09:54:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-19-2020 09:54:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-19-2020 06:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical query: No
AE has been
reported yet so
please leave this
query open till
parkinsonism will
be added in AE log.
Thanks
Oct-14-2020 14:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered will be reported in
AE
Oct-14-2020 05:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical query: if this
is a new diagnosis
please report the
event parkinsonism
in the AE log.
Thanks
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808628
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-06-2020 10:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
If No, specify reason:
the volunteer has been diagno
sed with Parkinsonism, he is
withdrawn from the interventi
on, he did not get the second
vaccine, but he is following u
p for drug immunogencitiy, sa
fety and efficacyInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808629
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 10:24:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808630
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 10:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 10:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 14:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 10:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-03-2020 10:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020 14:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LD2Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808631
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 14:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LD2Initial Entry
5.b
Date Location User Value Reason
Nov-03-2020 14:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4WPInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 14:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4WPInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 14:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4WRInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 14:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4WRInitial Entry
5.d
Date Location User Value Reason
Nov-03-2020 14:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4WSInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808632
Page 136 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Nov-03-2020 14:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4WSInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808633
Page 137 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-09-2020 15:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-09-2020 10:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-09-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to
"Status" is
ADVERSE EVENT
but "Specify Status"
is Provided.
Nov-09-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-09-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTTranscription Error
Nov-07-2020 10:26:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Adverse Event log
indicates treatment
was discontinued
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808634
Page 138 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
due to Parkinsonism
(Drug Withdrawn
indicated on the AE
line). If this is
correct, the status on
this EOT page
should be
ADVERSE
EVENT. Else,
clarify
Nov-06-2020 13:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
Adverse Event log
indicates treatment
was discontinued
due to Parkinsonism
(Drug Withdrawn
indicated on the AE
line). If this is
correct, the status on
this EOT page
should be
ADVERSE
EVENT. Else,
clarify
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-09-2020 10:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHANGE OF HEALTH STAT
US. PARTICIPANT IS REQUE
STING REMOVAL FROM ST
UDYInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808635
Page 139 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808636
Page 140 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-02-2020 11:00:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Closed Response satisfies
query
Nov-20-2020 12:30:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered patient did not report
any symptoms or
signs to the provider
before vaccination
Nov-20-2020 11:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Opened Clin: Please clarify
if there had been any
symptoms/signs
/concerns prior to
this new diagnosis
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
parkinsonismInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 UNK:UNKInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808637
Page 141 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020 09:47:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Closed Response satisfies
query
Oct-29-2020 13:21:26
(UTC-05:00) EasternACV0PFEINFP6000 Query 1: Answered this is a new
diagnosis
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808638
Page 142 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Oct-29-2020 11:57:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Opened Clin: Please clarify
of this is a new
diagnosis or
pre-existing
condition? If
pre-existing please
add to the Medical
History page
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
natural progression of park
insonismInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021
13:42:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 3:
ClosedResponse
satisfies query
Mar-03-2021
08:59:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
Answere
dTranscription
Error
Mar-03-2021
08:59:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
DRUG
WITHD
RAWNTranscription
Error
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808639
Page 143 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-03-2021
08:01:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 3:
OpenedCLINQUERY:
This event
occurred during
the first
treatment phase
(placebo) where
Vax 2 was not
administered in
response to the
event. As such,
please leave the
initial entry
here to match to
the first EOT
page status.
Revax Rx phase
is separate
Feb-19-2021
18:02:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse
satisfies query
Feb-19-2021
10:04:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dChanged
Information
Feb-19-2021
10:04:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOT AP
PLICAB
LEChanged
Information
Feb-19-2021
03:28:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedDM: Action
taken with
Study treatment
is updated as
'Drug
Withdrawn',
however subject
is revaccinated.
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808640
Page 144 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Kindly confirm
if action taken
should be
changed to 'Not
Applicable.
Please verify
and update.
Feb-19-2021
03:22:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedAnother query
raised.
Feb-19-2021
01:04:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedThe Adverse
Event Action
Taken is DRUG
WITHDRAWN
. As per CCG
"Drug
Withdrawn"
should be
selected if the
Second
vaccination
dose was not
administered
due to AE.
Please verify
and update data
accordingly.
Oct-27-2020
15:32:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
DRUG
WITHD
RAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808641
Page 145 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 15:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808642
Page 146 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808643
Page 147 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route,
use, formulation).
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
flu shotInitial Entry
5. Date:
Date Location User Value Reason
Nov-03-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808644
Page 148 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 11:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-25-2021 10:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-25-2021 10:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Transcription Error
Jan-22-2021 14:03:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per CRF completion
guidelines, initial
contact to determine
if subject can receive
study vaccine will be
documented in
REVAX_CONTACT
Visit. Per source, date
of initial contact is
13Jan2021. Please
clarify or confirm as
appropriate.
Jan-19-2021 15:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808645
Page 149 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021 15:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo a
t Vaccination 1/2Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808646
Page 150 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021 15:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 15:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808647
Page 151 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-19-2021 15:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808648
Page 152 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-19-2021 15:11:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808649
Page 153 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 15:12:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808650
Page 154 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021 15:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/19/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808651
Page 155 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-19-2021 15:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 15:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 15:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808652
Page 156 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 15:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 15:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 15:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 15:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4T4Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808653
Page 157 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4T4Initial Entry
5.b
Date Location User Value Reason
Jan-19-2021 16:59:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4T5Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-19-2021 16:59:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4T5Initial Entry
5.c
Date Location User Value Reason
Jan-19-2021 16:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW4T6Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-19-2021 16:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW4T6Initial Entry
5.d
Date Location User Value Reason
Jan-19-2021 16:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9C1HInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808654
Page 158 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Jan-19-2021 16:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9C1HInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808655
Page 159 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 15:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 15:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 16:59:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 15:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 15:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 16:59:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9C1FInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808656
Page 160 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 16:59:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9C1FInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808657
Page 161 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808658
Page 162 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-19-2021 15:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808659
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021 12:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808660
Page 164 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-09-2021 12:04:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021 12:04:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021 13:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-09-2021 12:04:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-09-2021 12:04:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021 13:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9C3NInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808661
Page 165 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Feb-09-2021 13:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9C3NInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808662
Page 166 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021 11:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808663
Page 167 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-09-2021 12:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808664
Page 168 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 11:28:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/9/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808665
Page 169 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-09-2021 11:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-09-2021 11:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Mar/9/2021Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808666
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Mar-09-2021
11:29:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Mar/9
/2021Initial Entry
Mar-09-2021
11:29:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Initial Entry
Mar-01-2021
12:20:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
Mar-01-2021
08:43:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Transcription Error
Feb-10-2021
03:27:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedIncorrect query
Feb-09-2021
16:45:21
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7210926;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808667
Page 171 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Canada) Visit 3 Date. Please
review and update as
appropriate.
Feb-09-2021
12:29:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/9/
2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-09-2021 11:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
Mar-09-2021 11:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Mar-01-2021 12:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-01-2021 08:43:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Feb-09-2021 12:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-09-2021 11:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
Mar-09-2021 11:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808668
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-02-2021 04:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-01-2021 12:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Mar-01-2021 08:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated the EOT2
Mar-01-2021 05:19:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLIN RE QUERY:
EOT2 (open label
phase) is marked as
COMPLETED but
subject has not
attended V103 (1
month follow up).
Please review if this
page has been
completed
prematurely prior to
V103; if so, please
clear this page.
Thank you.
Feb-26-2021 10:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-26-2021 10:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-25-2021 05:22:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
EOT2 (open label
phase) is marked as
COMPLETED but
subject has not
attended V103 (1
month follow up).
Please review if this
page has been
completed
prematurely prior to
V103; if so, please
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0808669
Page 173 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
clear this page.
Thank you.
Feb-23-2021 08:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY:
EOT2 (open label
phase) is marked as
COMPLETED but
subject has not
attended V103 (1
month follow up).
Please review if this
page has been
completed
prematurely prior to
V103; if so, please
clear this page.
Thank you.
Feb-09-2021 12:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-09-2021 11:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Mar-01-2021 12:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808670
Page 174 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-09-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-06-2020 11:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-06-2020 11:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-09-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Transcription Error
Sep-30-2020 11:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Sep-06-2020 11:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-06-2020 11:03:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808671
Page 175 of 175
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 15:06:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fe5\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808672