Document text
Page 1 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823836
Page 2 of 149
***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: 12181015 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/12/2020
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823837
Page 3 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12181015]
2.Birth Date: 1986
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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823838
Page 4 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823839
Page 5 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823840
Page 6 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathNov/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823841
Page 7 of 149
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823842
Page 8 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
2.Weight: [94.6]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [32.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823843
Page 9 of 149
***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: 12181015 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/12/2020
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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823844
Page 10 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/12/2020
2.Randomization Number: [116202]
3.Randomization Group: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823845
Page 11 of 149
***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: 12181015 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/12/2020
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 [BR8NGM]
5.bSample ID [BS729F]
5.cSample ID [BS729G]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823846
Page 12 of 149
***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: 12181015 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/12/2020
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 [BR8NGN]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823847
Page 13 of 149
***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: 12181015 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/12/2020 16:04
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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823848
Page 14 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823849
Page 15 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823850
Page 16 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823851
Page 17 of 149
***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: 12181015 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/3/2020
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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823852
Page 18 of 149
***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: 12181015 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/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NVL]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823853
Page 19 of 149
***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: 12181015 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/3/2020 12:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823854
Page 20 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823855
Page 21 of 149
***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: 12181015 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[collected at VAX3 visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823856
Page 22 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823857
Page 23 of 149
***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: 12181015 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: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823858
Page 24 of 149
***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: 12181015 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 [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823859
Page 25 of 149
***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: 12181015 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 [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823860
Page 26 of 149
***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: 12181015 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?
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823861
Page 27 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823862
Page 28 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823863
Page 29 of 149
***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: 12181015 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 [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823864
Page 30 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823865
Page 31 of 149
***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: 12181015 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 [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823866
Page 32 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identif
ierAdverse Even
tStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Bell's Palsy -
Left Jan/10/2021 UNK:
UNK NO
End Date Time:
Jan/21/2021 UNK:UNK
Repeating
Pages
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823867
Page 33 of 149
***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: 12181015 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)[Bell's Palsy - Left]
4.Start Date Time: Jan/10/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823868
Page 34 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823869
Page 35 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823870
Page 36 of 149
***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: 12181015 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[ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823871
Page 37 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823872
Page 38 of 149
***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: 12181015 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: //
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823873
Page 39 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823874
Page 40 of 149
***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: 12181015 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?
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823875
Page 41 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823876
Page 42 of 149
***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: 12181015 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?
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823877
Page 43 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823878
Page 44 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823879
Page 45 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823880
Page 46 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823881
Page 47 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823882
Page 48 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823883
Page 49 of 149
***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: 12181015 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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823884
Page 50 of 149
***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: 12181015 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?
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823885
Page 51 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823886
Page 52 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823887
Page 53 of 149
***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: 12181015 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/7/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823888
Page 54 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823889
Page 55 of 149
***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
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823890
Page 56 of 149
***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: 12181015 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: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823891
Page 57 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823892
Page 58 of 149
***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: 12181015 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/7/2021
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823893
Page 59 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823894
Page 60 of 149
***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: 12181015 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/7/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823895
Page 61 of 149
***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: 12181015 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/7/2021
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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823896
Page 62 of 149
***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: 12181015 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/7/2021
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 [BR8NZB]
5.bSample ID [BS72G3]
5.cSample ID [BS72G4]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823897
Page 63 of 149
***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: 12181015 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/7/2021
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 [BR8NZ8]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823898
Page 64 of 149
***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: 12181015 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/7/2021 12:35
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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823899
Page 65 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/7/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823900
Page 66 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823901
Page 67 of 149
***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: 12181015 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: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823902
Page 68 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823903
Page 69 of 149
***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: 12181015 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/27/2021
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:
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823904
Page 70 of 149
***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: 12181015 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/27/2021
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 [BR8NJX]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823905
Page 71 of 149
***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: 12181015 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/27/2021 10:45
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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823906
Page 72 of 149
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823907
Page 73 of 149
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/25/2021
3.Comments: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823908
Page 74 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823909
Page 75 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823910
Page 76 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823911
Page 77 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823912
Page 78 of 149
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/25/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823913
Page 79 of 149
***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: 12181015 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/7/2021
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823914
Page 80 of 149
***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: 12181015 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
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823915
Page 81 of 149
***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: 12181015 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
Approved Mar-10-2021 14:10:34 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823916
Page 82 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-12-2020 17:09:28 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823917
Page 83 of 149
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-13-2020 08:32:28 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823918
Page 84 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-07-2021 12:44:17 (UTC-07:00) Mountain
Time (US & Canada)ALL inclusion criteria met
NO exclusion criteria met
Not Applicable
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823919
Page 85 of 149
***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: 12181015 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
Approved Mar-10-2021 14:10:34 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-25-2021 12:18:35 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-29-2021 20:48:43 (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-27-2021 10:39:24 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823920
Page 86 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Laura Hammit Approved Jan-23-2021 07:19:35 (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-12-2021 17:20:32 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:25:57 (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 Dec-30-2020 18:45:40 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-04-2020 22:33:37 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823921
Page 87 of 149
***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: 12181015 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 Dec-03-2020 12:22:26 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-01-2020 20:45:22 (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.
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823922
Page 88 of 149
***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: 12181015 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-12-2020 17:05:45
(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-12-2020 17:05:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823923
Page 89 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-12-2020 17:07:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/12/2020Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823924
Page 90 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-12-2020 16:47:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12181015Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-12-2020 16:47:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1986Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-12-2020 17:07:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-12-2020 17:07:53
(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-12-2020 17:07:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AMERICAN INDIAN OR ALAS
KA NATIVEInitial Entry
090177e196ae3e9d\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-2021-5683-0823925
Page 91 of 149
***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: 12181015 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-13-2020 20:51:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-13-2020 08:34:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No medical history.
Corrected as
directed.
Nov-13-2020 04:04:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete
‘Medical History
form' at this visit. If
no medical history
present, Please add
Form level
comment “Not
Applicable”. Thank
you.
Nov-12-2020 17:08:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
090177e196ae3e9d\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-2021-5683-0823926
Page 92 of 149
***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: 12181015 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-12-2020 17:09:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 17:09:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 17:09:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823927
Page 93 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
94.6Initial Entry
3. Unit:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.7Initial Entry
090177e196ae3e9d\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-2021-5683-0823928
Page 94 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7.a
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-12-2020 17:28:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9d\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-2021-5683-0823929
Page 95 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-12-2020 17:29:11
(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-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-12-2020 17:29:11
(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-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823930
Page 96 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-12-2020 17:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823931
Page 97 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-12-2020 17:47:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-12-2020 17:47:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
116202Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823932
Page 98 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 09:06:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 09:06:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 09:09:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 09:06:50
(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-13-2020 09:06:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 09:10:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NGMTranscription Error
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823933
Page 99 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020 09:09:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NGMLInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 09:10:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-13-2020 09:10:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NGMTranscription Error
Nov-13-2020 09:09:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Nov-13-2020 09:09:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NGMLInitial Entry
5.b
Date Location User Value Reason
Dec-30-2020 18:45:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS729FInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-30-2020 18:45:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS729FInitial Entry
5.c
Date Location User Value Reason
Dec-30-2020 18:46:10 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e9d\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)
FDA-CBER-2021-5683-0823934
Page 100 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain
Time (US & Canada)Sample ID: BS729G
5.c Sample ID
Date Location User Value Reason
Dec-30-2020 18:46:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS729GInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823935
Page 101 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 09:10:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 09:10:52
(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-13-2020 09:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 09:10:52
(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-13-2020 09:10:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 09:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NGNInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823936
Page 102 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 09:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NGNInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823937
Page 103 of 149
***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: 12181015 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-12-2020 17:29:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-12-2020 17:29:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-12-2020 17:29:54
(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-12-2020 17:29:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020 16:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-12-2020 17:29:54
(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-12-2020 17:29:54
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9d\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-2021-5683-0823938
Page 104 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-12-2020 17:29:54
(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-12-2020 17:29:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-12-2020 17:29:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823939
Page 105 of 149
***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: 12181015 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-12-2020 17:30:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823940
Page 106 of 149
***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: 12181015 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-03-2020 12:22:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823941
Page 107 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2.a
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e9d\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-2021-5683-0823942
Page 108 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Temperature Location:
Date Location User Value Reason
Dec-03-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823943
Page 109 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-03-2020 12:22:56
(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-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-03-2020 12:22:56
(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-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823944
Page 110 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Dec-03-2020 12:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823945
Page 111 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 14:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 14:54:22
(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-03-2020 14:54:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 14:54:22
(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-03-2020 14:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020 14:54:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NVLInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823946
Page 112 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 14:54:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NVLInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823947
Page 113 of 149
***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: 12181015 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-03-2020 13:24:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-03-2020 13:24:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-03-2020 13:24:24
(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-03-2020 13:24:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020 12:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-03-2020 13:24:24
(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-03-2020 13:24:24
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9d\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-2021-5683-0823948
Page 114 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-03-2020 13:24:24
(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-03-2020 13:24:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-03-2020 13:24:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823949
Page 115 of 149
***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: 12181015 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-07-2021 16:09:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823950
Page 116 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 16:10:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 16:10:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-07-2021 16:10:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-07-2021 16:10:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
collected at VAX3 visitInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823951
Page 117 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823952
Page 118 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-12-2021 17:20:32
(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
Jan-15-2021 12:50:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-15-2021 11:51:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Participant has no
prior hx of Bell's,
no recent illness, no
labs were drawn
and no testing was
done. She was
treated with
Prednisone
60mg/day for 7
days and
Valacyclovir 3g/day
for 7 days.
Jan-15-2021 06:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
if subject has had
prior hx of Bell's,
any recent illness ie
prior to Bell's, what
treatment was
provided and results
of any testing
090177e196ae3e9d\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-2021-5683-0823953
Page 119 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
including Lyme
antibodies. Thanks
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bell's Palsy - LeftInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/10/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 14:47:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:UNKNew Information
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-12-2021 17:20:32 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e9d\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)
FDA-CBER-2021-5683-0823954
Page 120 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain
Time (US & Canada)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
Jan-12-2021 17:20:32
(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
Jan-15-2021 12:55:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-15-2021 11:47:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Pt has no other
history that would
lead to Bell's Palsy
diagnosis. It is
temporally related
to the vaccine.
Jan-15-2021 06:34:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
as to biological
basis for
determination as
'related' Thanks
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3e9d\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-2021-5683-0823955
Page 121 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-12-2021 17:20:32
(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
Jan-22-2021 14:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 14:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Jan-22-2021 14:47:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Bell's Palsy -
Left: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-12-2021 17:20:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e9d\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-2021-5683-0823956
Page 122 of 149
***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: 12181015 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-07-2021 16:13:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-07-2021 16:13:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-07-2021 16:13:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823957
Page 123 of 149
***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: 12181015 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-07-2021 12:40:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823958
Page 124 of 149
***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
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 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-08-2021 13:44:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-07-2021 22:55:38
(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-07-2021 12:41:14
(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-07-2021 12:41:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national re
commendations and confir
med to have received only
placebo at Vaccination 1/2Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823959
Page 125 of 149
***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: 12181015 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-07-2021 12:43:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823960
Page 126 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-07-2021 12:43:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Jan/7/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823961
Page 127 of 149
***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: 12181015 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-07-2021 12:44:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-07-2021 12:44:31
(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-07-2021 12:44:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823962
Page 128 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-07-2021 12:44:45
(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-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-07-2021 12:44:45
(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-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823963
Page 129 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Jan-07-2021 12:44:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823964
Page 130 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 16:10:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 16:10:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-07-2021 16:11:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 16:10:53
(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-07-2021 16:10:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
Date Location User Value Reason
Jan-07-2021 16:11:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NZBInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823965
Page 131 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-07-2021 16:11:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NZBInitial Entry
5.b
Date Location User Value Reason
Jan-07-2021 16:11:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72G3Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-07-2021 16:11:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72G3Initial Entry
5.c
Date Location User Value Reason
Jan-07-2021 16:12:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72G4Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-07-2021 16:12:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72G4Initial Entry
090177e196ae3e9d\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-2021-5683-0823966
Page 132 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 16:12:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 16:12:26
(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-07-2021 16:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 16:12:26
(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-07-2021 16:12:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
Date Location User Value Reason
Jan-07-2021 16:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NZ8Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823967
Page 133 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-07-2021 16:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NZ8Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823968
Page 134 of 149
***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: 12181015 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-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-07-2021 12:45:03
(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-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 12:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-07-2021 12:45:03
(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-07-2021 12:45:03
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9d\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-2021-5683-0823969
Page 135 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-07-2021 12:45:03
(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-07-2021 12:45:03
(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-07-2021 12:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823970
Page 136 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-08-2021 13:44:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-08-2021 13:44:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823971
Page 137 of 149
***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: 12181015 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-27-2021 10:39:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823972
Page 138 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 10:39:33
(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-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-27-2021 10:39:33
(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-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823973
Page 139 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Jan-27-2021 10:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823974
Page 140 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 12:47:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 12:47:56
(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-27-2021 12:48:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 12:47:56
(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-27-2021 12:47:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 12:48:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NJXInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823975
Page 141 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 12:48:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NJXInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823976
Page 142 of 149
***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: 12181015 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-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021 11:15:57
(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-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021 10:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021 11:15:57
(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-27-2021 11:15:57
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e9d\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-2021-5683-0823977
Page 143 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021 11:15:57
(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-27-2021 11:15:57
(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-27-2021 11:15:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823978
Page 144 of 149
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 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-26-2021 12:04:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-26-2021 08:35:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered completed
Feb-26-2021 04:43:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Feb-25-2021 12:18:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae3e9d\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-2021-5683-0823979
Page 145 of 149
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-25-2021 12:18:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-25-2021 12:18:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/25/2021Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823980
Page 146 of 149
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Mar-03-2021
02:58:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedInvalid query.
Mar-02-2021
14:05:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dWas instructed if
V101VAX3 is same
time as visit 3, enter
data into visit 3 then
to complete EOT
with date of visit 3
(same as
V101VAX3), EOT2
reflects date of
V103MTH1,
completion of
crossover. If this is
not correct, please
advise.
Feb-26-2021
18:50:52
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7479846;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-26-2021
08:33:19
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/2
5/202
1Initial Entry
2. Phase of Disposition:
090177e196ae3e9d\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-2021-5683-0823981
Page 147 of 149
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-26-2021 08:33:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-26-2021 08:33:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823982
Page 148 of 149
***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: 12181015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-07-2021 16:13:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-12-2020 17:47:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-12-2020 17:09:47
(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-07-2021 16:13:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/7/2021Initial Entry
Nov-12-2020 17:47:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Nov-12-2020 17:09:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823983
Page 149 of 149
***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: 12181015 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 16:16:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e9d\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0823984