Document text
Page 1 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918257
Page 2 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918258
Page 3 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10681066]
2.Birth Date: /1990
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918259
Page 4 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918260
Page 5 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918261
Page 6 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918262
Page 7 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atrial fibrillation] Comments
Start Date: Oct/17/2018 Comments
Ongoing: NO
End Date:
Dec/12/2019Comments
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918263
Page 8 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [78.0]
3.Unit: kg
4.Height: [186.0]
5.Unit: cm
6.Body Mass Index: [22.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918264
Page 9 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [71724]
3.Randomization Group: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918265
Page 10 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP1D0G]
5.bSample ID [BP1D0H]
5.cSample ID [BP1D0J]
5.dSample ID [BPHSDL]
5.eSample ID [BPHSDM]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918266
Page 11 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP1D07]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918267
Page 12 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: Aug/28/2020 14:18
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918268
Page 13 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918269
Page 14 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918270
Page 15 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918271
Page 16 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZPR7]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918272
Page 17 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/17/2020 17:03
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918273
Page 18 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918274
Page 19 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BNZPWJ]
5.bSample ID [BPHSKR]
5.cSample ID [BPHSKS]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918275
Page 20 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918276
Page 21 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918277
Page 22 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918278
Page 23 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918279
Page 24 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918280
Page 25 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918281
Page 26 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918282
Page 27 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918283
Page 28 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918284
Page 29 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918285
Page 30 of 162
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918286
Page 31 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918287
Page 32 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918288
Page 33 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918289
Page 34 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Left swollen cervical lym
ph node Aug/28/2020 1
8:00 NO
End Date Time:
Aug/30/2020 18:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Gum Swelling Aug/28/2020 1
8:00 NO
End Date Time:
Aug/30/2020 18:00
Repeating
Pages
3.ADVERSE EV
ENT 3 body aches Jan/13/2021 0
7:00 NO
End Date Time:
Jan/14/2021 19:00
Repeating
Pages
4.ADVERSE EV
ENT 4 chills Jan/13/2021 0
7:00 NO
End Date Time:
Jan/14/2021 19:00
Repeating
Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918290
Page 35 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Left swollen cervical lymph node]
4.Start Date Time: Aug/28/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 18:00
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?NO
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918291
Page 36 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918292
Page 37 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Gum Swelling]
4.Start Date Time: Aug/28/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 18:00
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?NO
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918293
Page 38 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918294
Page 39 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[body aches]
4.Start Date Time: Jan/13/2021 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 19:00
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918295
Page 40 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918296
Page 41 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Jan/13/2021 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 19:00
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?NO
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918297
Page 42 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918298
Page 43 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category Medication ErrorStart D
ateIs the medication error
Still OngoingStudy Medication
Errors ActionForm Instan
ce
1.MEDICATIO
N ERROR administered incorrect dosa
ge at vaccination 1 Aug/28/
2020 NO
End Date:
Aug/28/2020
NO ACTION TAKE
N Repeating
Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918299
Page 44 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Medication Error
1.Category: MEDICATION ERROR
2.Medication Error (Type of
Medication Error):[administered incorrect dosage at vaccination 1]
3.Start Date: Aug/28/2020
4.Is the medication error still
ongoing?NO
End Date:
Aug/28/2020
5.Latest Action Taken with Study
Treatment:NO ACTION TAKEN
6.Was a Concomitant Medication
given?NO
7.Was a Non-Drug Treatment given? NO
8.Did the Medication Error cause the
subject to be discontinued from the
study?NO
9.Was this medication error
associated with any adverse events?NO
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918300
Page 45 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918301
Page 46 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918302
Page 47 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918303
Page 48 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918304
Page 49 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918305
Page 50 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918306
Page 51 of 162
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918307
Page 52 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918308
Page 53 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918309
Page 54 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918310
Page 55 of 162
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918311
Page 56 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918312
Page 57 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918313
Page 58 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918314
Page 59 of 162
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918315
Page 60 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918316
Page 61 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/21/2020
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918317
Page 62 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918318
Page 63 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Dec/21/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918319
Page 64 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
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 [BNZP9N]
5.bSample ID [BNVX2F]
5.cSample ID [BNVX2G]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918320
Page 65 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
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 [BNZP9K]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918321
Page 66 of 162
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: Dec/21/2020 07:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918322
Page 67 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918323
Page 68 of 162
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918324
Page 69 of 162
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918325
Page 70 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918326
Page 71 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
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 [BNZPC8]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918327
Page 72 of 162
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/12/2021 07:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918328
Page 73 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918329
Page 74 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/9/2021
3.Comments: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918330
Page 75 of 162
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918331
Page 76 of 162
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918332
Page 77 of 162
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918333
Page 78 of 162
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918334
Page 79 of 162
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Feb/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918335
Page 80 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918336
Page 81 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918337
Page 82 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew Gentry Approved Mar-10-2021 07:30:48 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918338
Page 83 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-29-2020 15:26:59 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Applicable
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918339
Page 84 of 162
***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, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.aAug-29-2020 15:28:34 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerresolved with ablation
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918340
Page 85 of 162
***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, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.aAug-29-2020 15:28:34 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerresolved with ablation
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918341
Page 86 of 162
***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, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.aAug-29-2020 15:28:34 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerresolved with ablation
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918342
Page 87 of 162
***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, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.aAug-29-2020 15:28:34 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerresolved with ablation
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918343
Page 88 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-21-2020 08:45:32 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Applicable
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918344
Page 89 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew Gentry Approved Mar-10-2021 07:30:48 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Emily
Anglemyer N/A Feb-09-2021 14:54:36 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew Gentry Approved Jan-22-2021 11:53:38 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Emily
Anglemyer N/A Dec-17-2020 14:22:24 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918345
Page 90 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Andrew Gentry Approved Oct-29-2020 17:56:44 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Michaela
ODonoghue N/A Oct-29-2020 17:53:53 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rebecca Rassi Approved Oct-22-2020 16:35:07 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RebeccaRassi, 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.
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918346
Page 91 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-29-2020 15:23:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-29-2020 15:23:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918347
Page 92 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020 15:23:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/28/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918348
Page 93 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020 15:23:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10681066Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020 15:23:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1990Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020 15:26:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-29-2020 15:26:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020 15:26:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
WHITEInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918349
Page 94 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-29-2020 15:26:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/28/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918350
Page 95 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-29-2020 15:27:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020 15:27:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020 15:27:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918351
Page 96 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-29-2020 15:27:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:atrial fibrillati
on
Start Date: Oct/17/2018
Ongoing: NO
End Date:
Dec/12/20
19Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-29-2020 15:27:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-29-2020 15:27:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
atrial fibrillationInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-29-2020 15:27:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/17/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-29-2020 15:27:49
(UTC-07:00) MountainACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918352
Page 97 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) End Date:
Dec/12/2019
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918353
Page 98 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
78.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
186.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.5Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918354
Page 99 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Record Identifier
::1
Temperature: 98.3
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020 15:29:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
ORAL CAVITYInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918355
Page 100 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020 15:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020 15:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
71724Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918356
Page 101 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 15:30:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 15:30:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 15:30:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 15:30:01
(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.
Aug-29-2020 15:30:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 15:30:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D0GInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918357
Page 102 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 15:30:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D0GInitial Entry
5.b
Date Location User Value Reason
Aug-29-2020 15:30:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D0HInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020 15:30:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D0HInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D0JInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-29-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D0JInitial Entry
5.d
Date Location User Value Reason
Oct-21-2020 14:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHSDLInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918358
Page 103 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Oct-21-2020 14:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSDLInitial Entry
5.e
Date Location User Value Reason
Oct-21-2020 14:31:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHSDMInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-21-2020 14:31:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSDMInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918359
Page 104 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 15:30:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 15:30:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 15:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 15:30:54
(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.
Aug-29-2020 15:30:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 15:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D07Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918360
Page 105 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 15:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D07Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918361
Page 106 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/28/2020 14:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
LEFTInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918362
Page 107 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Aug-29-2020 15:31:56
(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
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-29-2020 15:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918363
Page 108 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-29-2020 15:32:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918364
Page 109 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 10:12:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918365
Page 110 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 10:33:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 09:08:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYNew Information
Sep-18-2020 10:33:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 10:33:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 02:07:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-21-2020 09:08:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0918366
Page 111 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-21-2020 09:08:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4New Information
Sep-21-2020 07:42:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Temperature" is
missing. kindly
review and update.
2.a Unit:
Date Location User Value Reason
Sep-18-2020 10:33:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 10:33:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918367
Page 112 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 10:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 10:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 10:15:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 11:37:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 10:33:57
(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.
Sep-18-2020 10:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918368
Page 113 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-21-2020 10:15:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNZPR7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 10:15:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPR7Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918369
Page 114 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 17:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0918370
Page 115 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-18-2020 10:34:25
(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
Sep-18-2020 10:34:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 10:35:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918371
Page 116 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 13:27:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918372
Page 117 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 13:27:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 13:27:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 08:15:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 04:53:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 13:27:21
(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.
Oct-15-2020 13:27:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918373
Page 118 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-16-2020 08:15:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sample ID: BNZPWJInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 08:15:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
BNZPWJInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 11:58:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHSKRInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 11:58:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSKRInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 11:58:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHSKSInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 11:58:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSKSInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918374
Page 119 of 162
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 13:27:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 13:27:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 13:28:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918375
Page 120 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918376
Page 121 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918377
Page 122 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerForm Created
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918378
Page 123 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerForm Created
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918379
Page 124 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 07:38:59
(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
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left swollen cervical lymph nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020 07:39:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 18:00Transcription Error
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918380
Page 125 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020 07:38:59
(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
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-18-2020 07:38:59
(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
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 02:05:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-21-2020 08:24:19
(UTC-07:00) MountainACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (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-2021-5683-0918381
Page 126 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
Sep-21-2020 08:24:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLETranscription Error
Sep-21-2020 04:40:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Latest Action
Taken with Study
Treatment" is
missing. Kindly
review and update
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-18-2020 07:39:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Left swollen
cervical lymph node
: Response to "What
was the outcome of
this adverse event?"
is 3 but End
Date/Time is
missing.
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (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-2021-5683-0918382
Page 127 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020 07:38:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918383
Page 128 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gum SwellingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 18:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918384
Page 129 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020 07:41:43
(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
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-18-2020 07:41:43
(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
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (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-2021-5683-0918385
Page 130 of 162
***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, Locked, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020 07:41:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918386
Page 131 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
body achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Jan/13/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NO
End Date Time:
Jan/14/2021 19:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918387
Page 132 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData 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
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) MountainACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918388
Page 133 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021 13:27:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918389
Page 134 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Jan/13/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NO
End Date Time:
Jan/14/2021 19:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918390
Page 135 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData 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
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) MountainACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918391
Page 136 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021 13:28:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918392
Page 137 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Audit Trail
Form Version: 17-Jul-2020 21:54 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918393
Page 138 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
MEDICATION ERRORInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
administered incorrect dosage a
t vaccination 1Initial Entry
3. Start Date:
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Aug/28/2020Initial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NO
End Date:
Aug/28/2020Initial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NO ACTION TAKENInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) MountainACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918394
Page 139 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Oct-29-2020 17:53:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918395
Page 140 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 14:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/17/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918396
Page 141 of 162
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-17-2020 14:23:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 14:22:48
(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.
Dec-17-2020 14:22:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confir
med to have received only p
lacebo at Vaccination 1/2Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918397
Page 142 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 08:44:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/21/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918398
Page 143 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-21-2020 08:45:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
OBTAINED
Date Written Consent Obtaine
d
Dec/21/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918399
Page 144 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-21-2020 08:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-21-2020 08:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-21-2020 08:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918400
Page 145 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-21-2020 08:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-21-2020 08:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-21-2020 16:27:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 08:47:13
(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-21-2020 08:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-21-2020 16:27:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNZP9NInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918401
Page 146 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-21-2020 16:27:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNZP9NInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 10:32:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNVX2FInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-22-2020 10:32:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVX2FInitial Entry
5.c
Date Location User Value Reason
Dec-22-2020 10:32:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNVX2GInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-22-2020 10:32:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVX2GInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918402
Page 147 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-21-2020 08:47:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-21-2020 08:47:34
(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-21-2020 16:27:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 08:47:34
(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-21-2020 08:47:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-21-2020 16:27:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNZP9KInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918403
Page 148 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-21-2020 16:27:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNZP9KInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918404
Page 149 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-21-2020 08:48:15
(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-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/21/2020 07:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-21-2020 08:48:15
(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-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RIGHTInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918405
Page 150 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Dec-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-21-2020 08:48:15
(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
Dec-21-2020 08:48:15
(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
Dec-21-2020 08:48:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918406
Page 151 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-24-2021
16:20:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-24-2021
09:26:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-24-2021
09:26:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Emily Anglemyer Data
Entry
:
Dec/1
7/202
0Transcription Error
Feb-23-2021
18:33:34
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Form has been
unfrozen, please
review and update as
appropriate.
Feb-23-2021
09:50:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Emily Anglemyer Query
1: An
swere
d17Dec20 is correct, can
form be unfrozen to fix
Feb-23-2021
00:38:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7351412;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918407
Page 152 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Dec-17-2020
14:23:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Emily Anglemyer Data
Entry
:
Dec/1
6/202
0Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020 14:23:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918408
Page 153 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 13:44:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918409
Page 154 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 13:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 13:44:32
(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-12-2021 17:18:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 13:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-12-2021 13:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021 17:18:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sample ID: BNZPC8Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918410
Page 155 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 17:18:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
BNZPC8Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918411
Page 156 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-12-2021 13:45:03
(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-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021 07:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-12-2021 13:45:03
(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-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918412
Page 157 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Jan-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-12-2021 13:45:03
(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-12-2021 13:45:03
(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-12-2021 13:45:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918413
Page 158 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021 14:54:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Feb/9/2021Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918414
Page 159 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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1. Contact Type:
Date Location User Value Reason
Feb-09-2021 14:54:50
(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-09-2021 14:54:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Contact:
Feb/9/2021Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918415
Page 160 of 162
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-10-2021
00:25:48
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edIncorrect query
Feb-09-2021
20:39:11
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7213873;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-09-2021
14:55:04
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Emily Anglemyer Data E
ntry:
Feb/9/2
021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-09-2021 14:55:04
(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-09-2021 14:55:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918416
Page 161 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020 13:28:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-29-2020 15:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-29-2020 15:27:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-15-2020 13:28:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Oct-15-2020 13:27:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-29-2020 15:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-29-2020 15:27:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918417
Page 162 of 162
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 16:34:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rebecca
RassiData Entry:
Click Here to EnableInitial Entry
090177e196ae2fde\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918418