Document text
Page 1 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823985
Page 2 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/17/2020
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823986
Page 3 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12181023]
2.Birth Date: 1990
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823987
Page 4 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823988
Page 5 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823989
Page 6 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathNov/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823990
Page 7 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Drug-Allergy: Methocarbamol]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iron Deficiency Anemia]
Start Date: Jun/20/2014
Ongoing: YES
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823991
Page 8 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/17/2020
2.Weight: [68.5]
3.Unit: kg
4.Height: [166.0]
5.Unit: cm
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823992
Page 9 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823993
Page 10 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/17/2020
2.Randomization Number: [116235]
3.Randomization Group: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823994
Page 11 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BS729W]
5.bSample ID [BS729V]
5.cSample ID [BR8NH5]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823995
Page 12 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BR8NH3]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823996
Page 13 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Nov/17/2020 16:26
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823997
Page 14 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823998
Page 15 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823999
Page 16 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824000
Page 17 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824001
Page 18 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NW8]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824002
Page 19 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Dec/7/2020 15:25
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824003
Page 20 of 157
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824004
Page 21 of 157
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/6/2021
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 [BR8NZ4]
5.bSample ID [BS72FX]
5.cSample ID [BS72FY]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824005
Page 22 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824006
Page 23 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824007
Page 24 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824008
Page 25 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824009
Page 26 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824010
Page 27 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824011
Page 28 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824012
Page 29 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824013
Page 30 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824014
Page 31 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824015
Page 32 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Alcohol withdra
wal Mar/3/2021 02:00 NO
End Date Time:
Mar/4/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Right forearm b
urn Mar/1/2021 UNK:
UNK YES Repeating
Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824016
Page 33 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Alcohol withdrawal]
4.Start Date Time: Mar/3/2021 02:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824017
Page 34 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[Withdrawal from binge drinking of alcohol]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021241112]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824018
Page 35 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right forearm burn]
4.Start Date Time: Mar/1/2021 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:
[Touching woodstove with forearm]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824019
Page 36 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824020
Page 37 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824021
Page 38 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824022
Page 39 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824023
Page 40 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824024
Page 41 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824025
Page 42 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824026
Page 43 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824027
Page 44 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824028
Page 45 of 157
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824029
Page 46 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824030
Page 47 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824031
Page 48 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824032
Page 49 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824033
Page 50 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824034
Page 51 of 157
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824035
Page 52 of 157
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824036
Page 53 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824037
Page 54 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824038
Page 55 of 157
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Jan/6/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824039
Page 56 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824040
Page 57 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824041
Page 58 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824042
Page 59 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824043
Page 60 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/11/2021
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824044
Page 61 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824045
Page 62 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Jan/11/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824046
Page 63 of 157
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/11/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824047
Page 64 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NZW]
5.bSample ID [BS72GR]
5.cSample ID [BS72GP]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824048
Page 65 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NZT]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824049
Page 66 of 157
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/11/2021 12:49
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824050
Page 67 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824051
Page 68 of 157
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824052
Page 69 of 157
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824053
Page 70 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824054
Page 71 of 157
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824055
Page 72 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BR8NKC]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824056
Page 73 of 157
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/2/2021 10:14
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
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824057
Page 74 of 157
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824058
Page 75 of 157
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824059
Page 76 of 157
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824060
Page 77 of 157
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824061
Page 78 of 157
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824062
Page 79 of 157
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824063
Page 80 of 157
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824064
Page 81 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/6/2021
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824065
Page 82 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824066
Page 83 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Laura Hammit Approved Mar-10-2021 13:45:10 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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.
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824067
Page 84 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-17-2020 18:43:44 (UTC-07:00) Mountain
Time (US & Canada)All inclusion criteria met. No exclusion criteria
met.
Not Applicable
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824068
Page 85 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 13:37:00 (UTC-07:00) Mountain
Time (US & Canada)ALL inclusion criteria met
NO exclusion criteria met
Not Applicable
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824069
Page 86 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Laura Hammit Approved Mar-10-2021 13:45:10 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-02-2021 09:48:09 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-23-2021 07:26:16 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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-11-2021 14:23:48 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824070
Page 87 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Laura Hammit Approved Jan-11-2021 13:38:29 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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-11-2021 13:37:28 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:37:23 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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-11-2021 13:37:00 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:36:41 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824071
Page 88 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, LauraHammit, 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-11-2021 13:36:07 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:28:27 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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-06-2021 13:11:43 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-07-2020 22:37:47 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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.
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824072
Page 89 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
N/A Dec-07-2020 15:07:13 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-02-2020 07:06:14 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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.
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824073
Page 90 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-17-2020 18:41:34
(UTC-07:00) Mountain
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
Nov-17-2020 18:41:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824074
Page 91 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-17-2020 18:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/17/2020Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824075
Page 92 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-17-2020 18:41:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12181023Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-17-2020 18:41:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1990Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-17-2020 18:42:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-17-2020 18:42:43
(UTC-07:00) Mountain
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
Nov-17-2020 18:42:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AMERICAN INDIAN OR ALAS
KA NATIVEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824076
Page 93 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 18:42:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824077
Page 94 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-17-2020 18:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-17-2020 18:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020 18:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824078
Page 95 of 157
***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, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-18-2020 17:29:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Drug-Allergy: M
ethocarbamol
Start Date: UNK/UNK/2018
Ongoing: YESclarified
Nov-17-2020 18:49:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Methocarba
mol
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-17-2020 18:49:42
(UTC-07:00) Mountain
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
Nov-18-2020
19:39:45
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
ClosedDiscrepancy has been
closed.
Nov-18-2020
17:29:46
(UTC-07:00)
MountainACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answeredclarified
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0824079
Page 96 of 157
***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, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US &
Canada)
Nov-18-2020
17:29:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Drug-Alle
rgy: Meth
ocarbamo
lclarified
Nov-17-2020
20:36:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedClarify
METHOCARBAMOL
as follows. Are you
reporting
METHOCARBAMOL
DRUG ALLERGY ?
Or
METHOCARBAMOL
DRUG
INTERACTION ?
METHOCARBAMOL
ACCIDENTAL
INGESTION ? or
other? If so then edit
to such. Otherwise,
please capture the
term in drug panel for
coding to WHO Drug.
Thank you.
Nov-17-2020
18:49:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Methocar
bamolInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-17-2020 18:49:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0824080
Page 97 of 157
***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, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-17-2020 18:49:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-17-2020 18:50:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Iron Deficiency
Anemia
Start Date: Jun/20/2014
Ongoing: YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824081
Page 98 of 157
***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, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Line/MH Number:
Date Location User Value Reason
Nov-17-2020 18:50:25
(UTC-07:00) Mountain
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
Mar-12-2021 13:37:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-12-2021 11:44:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered As noted on
Screening workbook,
she is a social
drinker and reported
consuming about 2
drinks/week.
Because this
increased use was
very new and
resulted in
hospitalization, it
was captured as an
AE/SAE.
Mar-12-2021 02:00:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Medical Monitor_
Per report, subjects
was "consuming
about 1 liter of
vodka per day". Pls
advise if she had a
MedHx of alcohol
use. Thanks
Mar-11-2021 04:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Candidate Medical Monitor_
Per report, subjects
was "consuming
about 1 liter of
vodka per day". Pls
advise if she had a
MedHx of alcohol
use. Thanks
Nov-17-2020 18:50:25 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0824082
Page 99 of 157
***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, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain
Time (US & Canada)Iron Deficiency Anemia
1.b Start Date:
Date Location User Value Reason
Nov-17-2020 18:50:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/20/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-17-2020 18:50:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824083
Page 100 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.5Initial Entry
3. Unit:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
166.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.9Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824084
Page 101 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-17-2020 18:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824085
Page 102 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824086
Page 103 of 157
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-17-2020 18:51:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824087
Page 104 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-17-2020 18:51:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-17-2020 18:51:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
116235Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824088
Page 105 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 18:52:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 18:52:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 18:53:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 18:52:05
(UTC-07:00) Mountain
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-17-2020 18:52:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 18:53:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS729WInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824089
Page 106 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 18:53:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS729WInitial Entry
5.b
Date Location User Value Reason
Nov-17-2020 18:53:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS729VInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-17-2020 18:53:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS729VInitial Entry
5.c
Date Location User Value Reason
Nov-17-2020 18:54:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NH5Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-17-2020 18:54:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NH5Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824090
Page 107 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 18:55:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 18:55:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 18:56:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 18:55:06
(UTC-07:00) Mountain
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-17-2020 18:55:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 18:56:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NH3Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824091
Page 108 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 18:56:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NH3Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824092
Page 109 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020 16:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824093
Page 110 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-17-2020 18:57:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824094
Page 111 of 157
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-17-2020 18:57:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824095
Page 112 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020 15:07:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824096
Page 113 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
2.a
Date Location User Value Reason
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 96.2
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-08-2020 23:06:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-08-2020 16:36:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Result is not
clinically
significant.
Dec-08-2020 01:52:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please confirm if
result is clinically
significant.
Dec-07-2020 15:07:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824097
Page 114 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.2 F
is outside of
Normal Range 97 -
99.5 F.
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.2Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-07-2020 15:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824098
Page 115 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824099
Page 116 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Dec-07-2020 15:07:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824100
Page 117 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-07-2020 15:56:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-07-2020 15:56:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 15:57:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-07-2020 15:56:36
(UTC-07:00) Mountain
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.
Dec-07-2020 15:56:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020 15:57:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NW8Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824101
Page 118 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 15:57:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NW8Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824102
Page 119 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020 15:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824103
Page 120 of 157
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-07-2020 15:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824104
Page 121 of 157
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 13:11:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824105
Page 122 of 157
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021 13:12:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021 13:12:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 13:13:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 13:12:32
(UTC-07:00) Mountain
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-06-2021 13:12:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021 13:13:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NZ4Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824106
Page 123 of 157
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-06-2021 13:13:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NZ4Initial Entry
5.b
Date Location User Value Reason
Jan-06-2021 13:13:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72FXInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-06-2021 13:13:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72FXInitial Entry
5.c
Date Location User Value Reason
Jan-06-2021 13:14:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72FYInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-06-2021 13:14:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72FYInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824107
Page 124 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824108
Page 125 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824109
Page 126 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Alcohol withdrawalInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2021 02:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Mar/4/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824110
Page 127 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-10-2021 04:39:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Alcohol
withdrawal:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability
/incapacity?Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824111
Page 128 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Withdrawal from binge drin
king of alcoholInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824112
Page 129 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 14:18:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-10-2021 04:39:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021241112Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824113
Page 130 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right forearm burnInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824114
Page 131 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
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
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Touching woodstove with f
orearmInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824115
Page 132 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 14:20:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824116
Page 133 of 157
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-06-2021 13:15:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-06-2021 13:15:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-06-2021 13:15:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824117
Page 134 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 08:44:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021confirmed as
correct date of
REVAX CONT
Jan-11-2021 13:36:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824118
Page 135 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 07:56:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-11-2021 23:08:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-11-2021 13:36:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-11-2021 13:36:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824119
Page 136 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-11-2021 13:36:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824120
Page 137 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-11-2021 13:36:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/11/2021Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824121
Page 138 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-11-2021 13:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-11-2021 13:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-11-2021 13:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824122
Page 139 of 157
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824123
Page 140 of 157
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Jan-11-2021 13:37:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824124
Page 141 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 14:24:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 14:24:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021 14:25:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-11-2021 14:24:47
(UTC-07:00) Mountain
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-11-2021 14:24:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 14:25:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NZWInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824125
Page 142 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 14:25:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NZWInitial Entry
5.b
Date Location User Value Reason
Jan-11-2021 14:26:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72GRInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-11-2021 14:26:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72GRInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 14:26:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72GPInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-11-2021 14:26:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72GPInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (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-2021-5683-0824126
Page 143 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 14:23:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 14:23:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021 14:24:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-11-2021 14:23:48
(UTC-07:00) Mountain
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-11-2021 14:23:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 14:24:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NZTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824127
Page 144 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 14:24:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NZTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824128
Page 145 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021 12:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824129
Page 146 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-11-2021 13:37:46
(UTC-07:00) Mountain
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-11-2021 13:37:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824130
Page 147 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-24-2021
17:34:58
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-24-2021
08:45:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per
query
Feb-24-2021
04:37:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM Requery#1: Thank
you for previous query
response, the form has
been unfrozen now
kindly update the
corresponding data
accordingly else
clarify.
Feb-23-2021
14:20:43
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dPlease unlock REVAX
CONT tab and I will
correct the date. It
should also be entered
as 06JAN2021.
Feb-23-2021
13:06:57
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7352967;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0824131
Page 148 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021
07:56:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/6/
2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021 07:56:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824132
Page 149 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021 09:48:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824133
Page 150 of 157
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824134
Page 151 of 157
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Feb-02-2021 09:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824135
Page 152 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-02-2021 11:36:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-02-2021 11:36:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-02-2021 11:37:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-02-2021 11:36:44
(UTC-07:00) Mountain
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-02-2021 11:36:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-02-2021 11:37:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NKCInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824136
Page 153 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Feb-02-2021 11:37:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NKCInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824137
Page 154 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021 10:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824138
Page 155 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-02-2021 11:09:13
(UTC-07:00) Mountain
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-02-2021 11:09:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824139
Page 156 of 157
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-06-2021 13:15:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-17-2020 18:51:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-17-2020 18:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-06-2021 13:15:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/6/2021Initial Entry
Nov-17-2020 18:51:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/17/2020Initial Entry
Nov-17-2020 18:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/17/2020Initial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824140
Page 157 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-01-2020 16:19:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e9b\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824141